Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00074035
Collaborator
National Cancer Institute (NCI) (NIH)
39
16
1
131
2.4
0

Study Details

Study Description

Brief Summary

RATIONALE: Pentostatin may be effective in treating chronic graft-versus-host disease by stopping the immune system from rejecting donor stem cells or donor white blood cells.

PURPOSE: This phase II trial is studying how well pentostatin works in treating patients with chronic graft-versus-host disease that is refractory (not responsive) to treatment with steroids.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

Primary

  • Determine the response rate in patients with refractory chronic graft-versus-host disease treated with pentostatin.

Secondary

  • Determine the time to next immunosuppressive agent (i.e., the time to progression from best response) in patients treated with this drug.

  • Determine the toxicity of this drug in these patients.

  • Determine the infection rate in patients treated with this drug.

  • Determine the pharmacokinetics of this drug in these patients.

  • Determine the changes in lymphocyte populations in patients treated with this drug.

  • Determine the survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive pentostatin IV over 20-30 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients who achieve a complete response after 6 courses receive 4 additional courses. Patients who achieve a partial response, minor response, or stable disease after 6 courses may receive up to 6 additional courses.

Patients are followed every 4 weeks for 1 year, every 3 months for 2 years, and then annually for 5 years.

PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
39 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Phase II Trial Of Intravenous Pentostatin For The Treatment Of Patients With Refractory Chronic Graft-Versus-Host Disease
Actual Study Start Date :
Dec 1, 2003
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pentostatin

treatment of pts with refractory graft vs host disease

Drug: pentostatin
4 mg/sq m IV infusion over 20-30 min q 2 weeks

Outcome Measures

Primary Outcome Measures

  1. Response Rate [3 months]

    Percentage of participants who had a complete or partial response defined by the Hopkins scoring system. A complete response is defined as the disappearance of signs and symptoms of chronic GVHD in all involved systems that is sustained for at lest 4 weeks. A partial response is an improvement by 2 or more points in at least one system score, which is sustained for at least 4 weeks, with no signs of worsening in others.

Secondary Outcome Measures

  1. Grade 3 or Higher Non-hematologic Adverse Events [Duration of treatment (up to 5 years)]

    Number of participants experiencing a grade 3, 4 or 5 clinically significant non-hematologic adverse events, at least possibly related to treatment.

  2. Overall Survival At 1 Year [1 year]

    Percentage of patients who were alive at 1 year.

  3. Overall Survival At 2 Years [2 year]

    Percentage of patients who were alive at 2 years.

Other Outcome Measures

  1. Pharmacokinetics Association Between Exposure and Response At 3 Months [3 months]

    The individual PK parameters will be derived by using a noncompartmental analysis of the plasma-concentration-time data

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  1. Histologic documentation of chronic GvHD following allogeneic HCT or donor lymphocyte infusion.

  2. Patients may have progressive, quiescent, or de novo onset chronic GvHD.

  3. Patients with extensive stage chronic GvHD requiring systemic immunosuppressive therapy are eligible. Patients with limited stage disease are excluded. Extensive stage is defined according to Seattle criteria (9) as either:

  • Generalized skin involvement or

  • Limited skin involvement or hepatic involvement with any one of the following:

  • Liver histology showing chronic progressive hepatitis, bridging necrosis or cirrhosis

  • Eye involvement (Schirmer's test with < 5 mm wetting)

  • Involvement of minor salivary glands or oral mucosa

  • Involvement of any other organ

  1. Patients must have failed treatment with, or experience progression after, prior corticosteroids for extensive stage chronic GvHD, as defined below.

4.1 Patients will be considered to have failed corticosteroids if they have any one of the following criteria:

  • Progressive disease or less than a minor response in any organ system despite 2 weeks on corticosteroid treatment at least 1 mg/kg methylprednisolone or equivalent.

  • Failure to achieve at least a minor response after at least 4 weeks of treatment with a dose of ≥ 0.5 mg/kg methylprednisolone or equivalent.

  • Achievement of less than a partial response at 8 weeks of corticosteroid treatment despite use of a dose ≥ 0.5 mg/kg methylprednisolone or equivalent.

  • Requirement of ≥ 0.5 mg/kg methylprednisolone or equivalent to maintain a partial response or better at 12 weeks of corticosteroid treatment.

  • Requirement of > 10 mg/kg methylprednisolone or equivalent to maintain a partial response or better at 18 weeks of corticosteroid treatment.

4.2 Patients with progression of extensive stage chronic GvHD after a prior history of treatment with at least 18 weeks of corticosteroids, now requiring the reintroduction of corticosteroids (> 10 mg/day methylprednisolone or equivalent) or an additional agent (including photopheresis, PUVA) for treatment.

  1. Patients with established chronic GvHD not improving or progressing on other immunosuppressive agents are also eligible if steroid refractoriness has been established previously.

  2. Age ≥ 18 years

  3. Performance Status 0-3

  4. Patients on mechanical ventilation are excluded.

  5. No active infection. Patients with active infection requiring antibiotic therapy are not eligible until infection is controlled.

  6. No HIV infection. Patients with HIV infection are excluded because of safety concerns in this patient population.

  7. Non-pregnant and non-nursing. Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial (although it is unlikely that successful pregnancy will occur in patients with chronic GvHD). Appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (Norplant®), or double barrier method (diaphragm plus condom).

  8. Required Initial Laboratory Values:

  • Calc. Creatinine Clearance ≥ 30 mL/min/1.73 m^2

  • ANC > 1000/μL

  • Platelets > 50,000/μL without transfusion

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tunnell Cancer Center at Beebe Medical Center Lewes Delaware United States 19958
2 CCOP - Christiana Care Health Services Newark Delaware United States 19713
3 University of Illinois Cancer Center Chicago Illinois United States 60612-7243
4 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
5 Greenebaum Cancer Center at University of Maryland Medical Center Baltimore Maryland United States 21201
6 Union Hospital Cancer Program at Union Hospital Elkton Maryland United States 21921
7 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
8 Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey United States 08043
9 New York Weill Cornell Cancer Center at Cornell University New York New York United States 10021
10 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
11 Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina United States 27157-1096
12 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus Ohio United States 43210-1240
13 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104-4283
14 Fox Chase Cancer Center - Philadelphia Philadelphia Pennsylvania United States 19111-2497
15 Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital Pittsburgh Pennsylvania United States 15224-1791
16 Virginia Commonwealth University Massey Cancer Center Richmond Virginia United States 23298-0037

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Sherif S. Farag, MD, PhD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00074035
Other Study ID Numbers:
  • CALGB-100101
  • U10CA031946
  • CDR0000341678
First Posted:
Dec 11, 2003
Last Update Posted:
Nov 3, 2021
Last Verified:
Oct 1, 2021
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Between December 2003 and March 2008, 39 participants were recruited to this study.
Pre-assignment Detail 1 participant cancelled prior to receiving treatment and is excluded from all analyses.
Arm/Group Title Pentostatin
Arm/Group Description pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
Period Title: Overall Study
STARTED 38
COMPLETED 38
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title Pentostatin
Arm/Group Description pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
Overall Participants 38
Age (years) [Median (Full Range) ]
Median (Full Range) [years]
48
Sex: Female, Male (Count of Participants)
Female
13
34.2%
Male
25
65.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
2
5.3%
Not Hispanic or Latino
29
76.3%
Unknown or Not Reported
7
18.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
1
2.6%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
3
7.9%
White
30
78.9%
More than one race
1
2.6%
Unknown or Not Reported
3
7.9%
Region of Enrollment (count of participants) [Number]
United States
38
100%

Outcome Measures

1. Primary Outcome
Title Response Rate
Description Percentage of participants who had a complete or partial response defined by the Hopkins scoring system. A complete response is defined as the disappearance of signs and symptoms of chronic GVHD in all involved systems that is sustained for at lest 4 weeks. A partial response is an improvement by 2 or more points in at least one system score, which is sustained for at least 4 weeks, with no signs of worsening in others.
Time Frame 3 months

Outcome Measure Data

Analysis Population Description
3 patients died before the 3 month evaluation and were not evaluated for the primary endpoint
Arm/Group Title Pentostatin
Arm/Group Description pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
Measure Participants 35
Number [percentage of participants]
20
52.6%
2. Secondary Outcome
Title Grade 3 or Higher Non-hematologic Adverse Events
Description Number of participants experiencing a grade 3, 4 or 5 clinically significant non-hematologic adverse events, at least possibly related to treatment.
Time Frame Duration of treatment (up to 5 years)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Pentostatin
Arm/Group Description pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
Measure Participants 38
Fatigue
3
7.9%
Renal failure
4
10.5%
Anorexia
2
5.3%
Infection
10
26.3%
CNS hemmorrhage
1
2.6%
Rash
1
2.6%
Personality/behavioral
1
2.6%
Pneumonitis
1
2.6%
3. Secondary Outcome
Title Overall Survival At 1 Year
Description Percentage of patients who were alive at 1 year.
Time Frame 1 year

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Pentostatin
Arm/Group Description pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
Measure Participants 38
Number [percentage of participants]
53
139.5%
4. Secondary Outcome
Title Overall Survival At 2 Years
Description Percentage of patients who were alive at 2 years.
Time Frame 2 year

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Pentostatin
Arm/Group Description pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
Measure Participants 38
Number [percentage of participants]
50
131.6%
5. Other Pre-specified Outcome
Title Pharmacokinetics Association Between Exposure and Response At 3 Months
Description The individual PK parameters will be derived by using a noncompartmental analysis of the plasma-concentration-time data
Time Frame 3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description

Adverse Events

Time Frame
Adverse Event Reporting Description 34 participants were evaluable for adverse events
Arm/Group Title Pentostatin
Arm/Group Description pentostatin: 4 mg/m^2 IV infusion over 20-30 min q 2 weeks
All Cause Mortality
Pentostatin
Affected / at Risk (%) # Events
Total / (NaN)
Serious Adverse Events
Pentostatin
Affected / at Risk (%) # Events
Total 14/34 (41.2%)
Blood and lymphatic system disorders
Hemoglobin decreased 11/34 (32.4%) 16
Cardiac disorders
Atrial tachycardia 1/34 (2.9%) 1
Cardiac disorder 1/34 (2.9%) 1
Edema 1/34 (2.9%) 2
Sinus tachycardia 1/34 (2.9%) 1
Eye disorders
Dry eye syndrome 4/34 (11.8%) 8
Eye disorder 1/34 (2.9%) 1
Eye pain 1/34 (2.9%) 1
Photophobia 1/34 (2.9%) 1
Gastrointestinal disorders
Abdominal pain 1/34 (2.9%) 1
Constipation 1/34 (2.9%) 1
Diarrhea 6/34 (17.6%) 8
Dry mouth 4/34 (11.8%) 5
Dysphagia 1/34 (2.9%) 2
Ear, nose and throat examination abnormal 2/34 (5.9%) 2
Gastric hemorrhage 1/34 (2.9%) 1
Gastrointestinal disorder 1/34 (2.9%) 1
Nausea 3/34 (8.8%) 3
Vomiting 2/34 (5.9%) 2
General disorders
Chills 1/34 (2.9%) 1
Edema limbs 1/34 (2.9%) 1
Fatigue 3/34 (8.8%) 4
Fever 2/34 (5.9%) 2
General symptom 1/34 (2.9%) 1
Injection site reaction 1/34 (2.9%) 1
Localized edema 2/34 (5.9%) 2
Pain 3/34 (8.8%) 3
Hepatobiliary disorders
Hepatobiliary disease 1/34 (2.9%) 4
Immune system disorders
Immune system disorder 1/34 (2.9%) 2
Infections and infestations
Catheter related infection 1/34 (2.9%) 1
Infection without neutropenia 3/34 (8.8%) 4
Opportunistic infection 1/34 (2.9%) 1
Phlebitis infective 1/34 (2.9%) 1
Sinusitis 1/34 (2.9%) 1
Injury, poisoning and procedural complications
Vascular access complication 1/34 (2.9%) 1
Investigations
Alanine aminotransferase increased 9/34 (26.5%) 15
Alkaline phosphatase 4/34 (11.8%) 8
Alkaline phosphatase increased 5/34 (14.7%) 7
Aspartate aminotransferase increased 11/34 (32.4%) 17
Blood bilirubin increased 7/34 (20.6%) 11
Coagulopathy 1/34 (2.9%) 1
Creatinine increased 8/34 (23.5%) 12
Laboratory test abnormal 4/34 (11.8%) 7
Leukocyte count decreased 7/34 (20.6%) 11
Lymphocyte count decreased 2/34 (5.9%) 3
Neutrophil count decreased 5/34 (14.7%) 5
Platelet count decreased 8/34 (23.5%) 11
Serum cholesterol increased 2/34 (5.9%) 2
Weight loss 2/34 (5.9%) 5
Metabolism and nutrition disorders
Anorexia 4/34 (11.8%) 5
Blood bicarbonate decreased 3/34 (8.8%) 6
Blood glucose increased 7/34 (20.6%) 8
Dehydration 5/34 (14.7%) 7
Iron overload 1/34 (2.9%) 1
Serum albumin decreased 7/34 (20.6%) 9
Serum calcium decreased 7/34 (20.6%) 9
Serum glucose decreased 1/34 (2.9%) 1
Serum magnesium decreased 4/34 (11.8%) 7
Serum magnesium increased 1/34 (2.9%) 1
Serum phosphate decreased 2/34 (5.9%) 3
Serum potassium decreased 2/34 (5.9%) 4
Serum potassium increased 3/34 (8.8%) 3
Serum sodium decreased 6/34 (17.6%) 10
Serum sodium increased 1/34 (2.9%) 1
Musculoskeletal and connective tissue disorders
Muscle weakness 2/34 (5.9%) 4
Muscle weakness lower limb 1/34 (2.9%) 1
Musculoskeletal disorder 2/34 (5.9%) 4
Nervous system disorders
Dizziness 1/34 (2.9%) 1
Headache 3/34 (8.8%) 3
Intracranial hemorrhage 1/34 (2.9%) 1
Tremor 2/34 (5.9%) 2
Psychiatric disorders
Anxiety 2/34 (5.9%) 2
Confusion 1/34 (2.9%) 1
Insomnia 1/34 (2.9%) 1
Personality change 1/34 (2.9%) 1
Renal and urinary disorders
Renal failure 4/34 (11.8%) 4
Reproductive system and breast disorders
Erectile dysfunction 1/34 (2.9%) 1
Respiratory, thoracic and mediastinal disorders
Cough 1/34 (2.9%) 1
Dyspnea 3/34 (8.8%) 4
Hypoxia 3/34 (8.8%) 3
Pleural effusion 1/34 (2.9%) 2
Pneumonitis 1/34 (2.9%) 1
Voice alteration 1/34 (2.9%) 1
Skin and subcutaneous tissue disorders
Dry skin 1/34 (2.9%) 1
Pruritus 2/34 (5.9%) 3
Rash desquamating 2/34 (5.9%) 3
Skin disorder 1/34 (2.9%) 1
Vascular disorders
Hypertension 1/34 (2.9%) 3
Hypotension 3/34 (8.8%) 3
Thrombosis 2/34 (5.9%) 2
Other (Not Including Serious) Adverse Events
Pentostatin
Affected / at Risk (%) # Events
Total 30/34 (88.2%)
Blood and lymphatic system disorders
Hemoglobin decreased 15/34 (44.1%) 67
Cardiac disorders
Arrhythmia supraventricular 1/34 (2.9%) 2
Atrial fibrillation 1/34 (2.9%) 2
Cardiac disorder 3/34 (8.8%) 6
Edema 3/34 (8.8%) 13
Myocardial ischemia 1/34 (2.9%) 1
Sinus tachycardia 4/34 (11.8%) 15
Endocrine disorders
Cushingoid 1/34 (2.9%) 8
Eye disorders
Cataract 1/34 (2.9%) 1
Dry eye syndrome 5/34 (14.7%) 19
Extraocular muscle paresis 1/34 (2.9%) 2
Eye disorder 2/34 (5.9%) 4
Eye pain 1/34 (2.9%) 2
Glaucoma 1/34 (2.9%) 1
Photophobia 3/34 (8.8%) 10
Vision blurred 4/34 (11.8%) 5
Gastrointestinal disorders
Abdominal distension 1/34 (2.9%) 1
Abdominal pain 1/34 (2.9%) 2
Constipation 6/34 (17.6%) 20
Diarrhea 9/34 (26.5%) 13
Dry mouth 5/34 (14.7%) 10
Dyspepsia 1/34 (2.9%) 4
Dysphagia 3/34 (8.8%) 5
Ear, nose and throat examination abnormal 3/34 (8.8%) 7
Esophageal stenosis 1/34 (2.9%) 1
Esophagitis 3/34 (8.8%) 6
Mucositis oral 1/34 (2.9%) 3
Nausea 11/34 (32.4%) 22
Oral pain 1/34 (2.9%) 1
Vomiting 4/34 (11.8%) 9
General disorders
Chest pain 1/34 (2.9%) 1
Chills 2/34 (5.9%) 2
Edema limbs 3/34 (8.8%) 6
Fatigue 12/34 (35.3%) 33
Fever 3/34 (8.8%) 4
Gait abnormal 1/34 (2.9%) 1
General symptom 2/34 (5.9%) 3
Ill-defined disorder 1/34 (2.9%) 1
Pain 7/34 (20.6%) 23
Hepatobiliary disorders
Hepatic failure 1/34 (2.9%) 1
Hepatobiliary disease 2/34 (5.9%) 3
Immune system disorders
Hypersensitivity 1/34 (2.9%) 1
Immune system disorder 1/34 (2.9%) 5
Infections and infestations
Bladder infection 2/34 (5.9%) 2
Infection 2/34 (5.9%) 2
Infection without neutropenia 4/34 (11.8%) 6
Opportunistic infection 1/34 (2.9%) 1
Otitis media 1/34 (2.9%) 1
Pneumonia 3/34 (8.8%) 3
Skin infection 1/34 (2.9%) 3
Tooth infection 1/34 (2.9%) 2
Upper respiratory infection 3/34 (8.8%) 7
Ureteritis 1/34 (2.9%) 2
Urinary tract infection 1/34 (2.9%) 1
Wound infection 1/34 (2.9%) 1
Injury, poisoning and procedural complications
Bruising 1/34 (2.9%) 1
Investigations
Activated partial thromboplastin time prolonged 1/34 (2.9%) 1
Alanine aminotransferase increased 20/34 (58.8%) 61
Alkaline phosphatase 7/34 (20.6%) 27
Alkaline phosphatase increased 7/34 (20.6%) 16
Aspartate aminotransferase increased 20/34 (58.8%) 72
Bilirubin associated with graft versus host disease (GVHD) for BMT studies 1/34 (2.9%) 1
Blood bilirubin increased 6/34 (17.6%) 10
Creatinine increased 10/34 (29.4%) 23
Gamma-glutamyltransferase increased 1/34 (2.9%) 4
INR increased 1/34 (2.9%) 1
Laboratory test abnormal 6/34 (17.6%) 27
Leukocyte count decreased 11/34 (32.4%) 28
Lymphocyte count decreased 5/34 (14.7%) 27
Neutrophil count decreased 7/34 (20.6%) 15
Platelet count decreased 15/34 (44.1%) 46
Serum cholesterol increased 4/34 (11.8%) 4
Weight loss 3/34 (8.8%) 6
Metabolism and nutrition disorders
Acidosis 1/34 (2.9%) 1
Alkalosis 1/34 (2.9%) 1
Anorexia 3/34 (8.8%) 6
Blood bicarbonate decreased 3/34 (8.8%) 5
Blood glucose increased 15/34 (44.1%) 71
Dehydration 2/34 (5.9%) 3
Iron overload 1/34 (2.9%) 3
Serum albumin decreased 6/34 (17.6%) 11
Serum calcium decreased 10/34 (29.4%) 13
Serum calcium increased 2/34 (5.9%) 5
Serum glucose decreased 4/34 (11.8%) 6
Serum magnesium decreased 4/34 (11.8%) 8
Serum magnesium increased 2/34 (5.9%) 4
Serum phosphate decreased 3/34 (8.8%) 7
Serum potassium decreased 5/34 (14.7%) 6
Serum potassium increased 5/34 (14.7%) 13
Serum sodium decreased 11/34 (32.4%) 18
Musculoskeletal and connective tissue disorders
Arthralgia 2/34 (5.9%) 5
Back pain 2/34 (5.9%) 3
Bone pain 2/34 (5.9%) 2
Joint disorder 2/34 (5.9%) 5
Muscle weakness 2/34 (5.9%) 4
Muscle weakness lower limb 3/34 (8.8%) 6
Musculoskeletal disorder 5/34 (14.7%) 5
Myositis 1/34 (2.9%) 1
Pain in extremity 2/34 (5.9%) 6
Nervous system disorders
Ataxia 1/34 (2.9%) 1
Cognitive disturbance 1/34 (2.9%) 1
Depressed level of consciousness 1/34 (2.9%) 3
Dizziness 2/34 (5.9%) 2
Headache 2/34 (5.9%) 5
Neurological disorder NOS 2/34 (5.9%) 2
Peripheral motor neuropathy 3/34 (8.8%) 4
Peripheral sensory neuropathy 3/34 (8.8%) 11
Tremor 1/34 (2.9%) 1
Psychiatric disorders
Anxiety 1/34 (2.9%) 12
Confusion 1/34 (2.9%) 1
Depression 3/34 (8.8%) 7
Insomnia 2/34 (5.9%) 3
Renal and urinary disorders
Glomerular filtration rate decreased 1/34 (2.9%) 1
Proteinuria 1/34 (2.9%) 2
Renal failure 1/34 (2.9%) 1
Urogenital disorder 1/34 (2.9%) 4
Reproductive system and breast disorders
Erectile dysfunction 1/34 (2.9%) 3
Pelvic pain 1/34 (2.9%) 1
Reproductive tract disorder 1/34 (2.9%) 1
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis 1/34 (2.9%) 1
Aspiration 1/34 (2.9%) 1
Cough 4/34 (11.8%) 6
Dyspnea 9/34 (26.5%) 16
Epistaxis 1/34 (2.9%) 2
Hypoxia 1/34 (2.9%) 1
Pleural effusion 3/34 (8.8%) 5
Pleuritic pain 1/34 (2.9%) 1
Skin and subcutaneous tissue disorders
Alopecia 1/34 (2.9%) 10
Dry skin 3/34 (8.8%) 6
Erythema multiforme 1/34 (2.9%) 1
Nail disorder 1/34 (2.9%) 2
Pain of skin 2/34 (5.9%) 6
Pruritus 1/34 (2.9%) 5
Rash desquamating 11/34 (32.4%) 63
Rash/desquamation associated with graft versus host disease (GVHD) for BMT studies 1/34 (2.9%) 1
Skin disorder 4/34 (11.8%) 20
Skin hyperpigmentation 1/34 (2.9%) 2
Skin ulceration 1/34 (2.9%) 2
Sweating 1/34 (2.9%) 1
Vascular disorders
Flushing 1/34 (2.9%) 1
Hypertension 4/34 (11.8%) 8
Hypotension 1/34 (2.9%) 1
Thrombosis 1/34 (2.9%) 3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title Sherif S. Farag, M.D., Ph.D.
Organization The Ohio State University Medical Center
Phone
Email farag-1@medctr.osu.edu
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00074035
Other Study ID Numbers:
  • CALGB-100101
  • U10CA031946
  • CDR0000341678
First Posted:
Dec 11, 2003
Last Update Posted:
Nov 3, 2021
Last Verified:
Oct 1, 2021