Study of Immune Response Modifier in the Treatment of Hematologic Malignancies

• Sponsor: Masonic Cancer Center, University of Minnesota (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00276159
• Collaborator: Pfizer (Industry)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 34
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia	Drug: 852A	Phase 2

Detailed Description

852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of 852A Administered Subcutaneously in Patients With Hematologic Malignancies Not Responding to Standard Treatment
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 852A Treatment Patients receiving at least one dose of 852A.	Drug: 852A; Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.; Other Names: Molecule 852A S-32865

Outcome Measures

Primary Outcome Measures

1. Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors [Up to Week 12]

   Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = <5% blasts with hematopoietic recovery (absolute neutrophil count >500) at 4 weeks.

Secondary Outcome Measures

1. Number of Patients Who Received Steroids [Up to Week 12]

   Number of patients who received steroids allowing successful continuation of therapy.

2. Measure of Immune Activation With Correlative Laboratory Studies [Up to Week 12]

3. Peak Concentrations of 852A [Up to Week 12]

   Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Subjects are eligible for the study if they meet all of the following

Inclusion Criteria:

• Diagnosis of one of the following hematologic malignancies not responding to at least 2 standard treatment regimens. Any criteria for persistent or recurrent disease acceptable, i.e. ≥5% blasts for acute leukemia.

• acute lymphoblastic leukemia (ALL)

• acute myeloid leukemia (AML)

• non-Hodgkin's lymphoma (NHL)

• Hodgkin's lymphoma (HL)

• multiple myeloma (MM)

• chronic lymphocytic leukemia (CLL)

• Performance status - Karnofsky > 50% for patients > 10 years of age or Lansky >50% for patients < 10 year of age

• Normal organ function within 14 days of study entry

• If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation. A female is considered to be of childbearing potential unless she has had her uterus removed, had a double oophorectomy, or has been amenorrheic for at least 6 months after chemotherapy

Exclusion Criteria:

• Had/have the following prior/concurrent therapy:

• Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed)

• Investigational drugs/agents within 14 days of first dose of 852A

• Immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose)

• Drugs known to induce QT interval prolongation and/or induce Torsades De Pointes unless best available drug required to treat life-threatening conditions

• Radiotherapy within 4 weeks of the first dose of 852A

• Hematopoietic cell transplantation 4 weeks of first dose of 852A

• Active infection or fever > 38.5°C within 3 days of first dose of 852A

• Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication

• History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk

• Uncontrolled intercurrent or chronic illness

• Active autoimmune disease requiring immunosuppressive therapy within 30 days

• Active hepatitis B or C with evidence of ongoing viral replication

• Hyperthyroidism

• Uncontrolled seizure disorder

• Active coagulation disorder not controlled with medication

• Pregnant or lactating

• Concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas adequately treated

• Proven active central nervous system (CNS) disease

• Human Immunodeficiency Virus (HIV) positive

• Congenital long QT syndrome or abnormal baseline QTc interval (> 450 msec in males and

470 msec in females) after Bazett's correction (QTc msec = QT msec / square root of the RR interval in seconds) on screening electrocardiogram (ECG).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• Masonic Cancer Center, University of Minnesota
• Pfizer

Investigators

• Principal Investigator: Sarah Cooley, MD, Masonic Cancer Center, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Masonic Cancer Center, University of Minnesota
• ClinicalTrials.gov Identifier: NCT00276159
• Other Study ID Numbers: 05US02IMP-852A; MT2005-20; 2005LS057; 0509M73467; NCT00326937
• First Posted: Jan 13, 2006
• Last Update Posted: Sep 4, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Masonic Cancer Center, University of Minnesota: Leukemia; Lymphoma; Myeloma; Hematology; 852A; IRM; Oncology
• Additional relevant MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Hematologic Neoplasms

Study Results

Participant Flow

Arm/Group Title	852A Treatment
Arm/Group Description	Patients receiving at least 12 doses of 852A.
Period Title: Overall Study
STARTED	6
COMPLETED	0
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	852A Treatment
Arm/Group Description	Patients receiving at least 12 doses of 852A.
Overall Participants	6
Age (Count of Participants)
<=18 years	2 33.3%
Between 18 and 65 years	3 50%
>=65 years	1 16.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.8 (23.32)
Sex: Female, Male (Count of Participants)
Female	1 16.7%
Male	5 83.3%
Region of Enrollment (participants) [Number]
United States	6 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors
Description	Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = <5% blasts with hematopoietic recovery (absolute neutrophil count >500) at 4 weeks.
Time Frame	Up to Week 12

Outcome Measure Data

Analysis Population Description

Includes patients receiving at least 12 doses of 852A study drug.

Arm/Group Title	852A Treatment
Arm/Group Description	Patients receiving at least 12 doses of 852A.
Measure Participants	6
Stable Disease	1 16.7%
Partial Response	1 16.7%
Progressive Disease	4 66.7%

2. Secondary Outcome

Title	Number of Patients Who Received Steroids
Description	Number of patients who received steroids allowing successful continuation of therapy.
Time Frame	Up to Week 12

Outcome Measure Data

Analysis Population Description

Includes patients receiving at least 12 doses of 852A study drug.

Arm/Group Title	852A Treatment
Arm/Group Description	Patients receiving at least 12 doses of 852A.
Measure Participants	6
Number [Participants]	2 33.3%

3. Secondary Outcome

Title	Measure of Immune Activation With Correlative Laboratory Studies
Time Frame	Up to Week 12

Outcome Measure Data

Analysis Population Description

Analysis not done to sale of agent - unable to perform.

Arm/Group Title	852A Treatment
Arm/Group Description	Patients receiving at least 12 doses of 852A.
Measure Participants	0

4. Secondary Outcome

Title	Peak Concentrations of 852A
Description	Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.
Time Frame	Up to Week 12

Outcome Measure Data

Analysis Population Description

Not able to analysis due to sale of agent - unable to perform.

Arm/Group Title	852A Treatment
Arm/Group Description	Patients receiving at least 12 doses of 852A.
Measure Participants	0

Adverse Events

Time Frame	Day 1 of Treatment through Week 12
Arm/Group Title	852A Treatment
Arm/Group Description	Patients receiving at least 12 doses of 852A.
All Cause Mortality
	852A Treatment
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	852A Treatment
	Affected / at Risk (%)	# Events
Total	4/6 (66.7%)
General disorders
Death	2/6 (33.3%)	2
Infections and infestations
Febrile neutropenia	1/6 (16.7%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	1/6 (16.7%)	1
Other (Not Including Serious) Adverse Events
	852A Treatment
	Affected / at Risk (%)	# Events
Total	4/6 (66.7%)
Blood and lymphatic system disorders
Edema	1/6 (16.7%)	2
Gastrointestinal disorders
Nausea	4/6 (66.7%)	5
General disorders
Fatigue	4/6 (66.7%)	10
Fever	2/6 (33.3%)	4
Chills	4/6 (66.7%)	5
Musculoskeletal and connective tissue disorders
Myalgia	3/6 (50%)	10
Respiratory, thoracic and mediastinal disorders
Cough	2/6 (33.3%)	3
Dyspnea	2/6 (33.3%)	4
Skin and subcutaneous tissue disorders
Diaphoresis	3/6 (50%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.