PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00090870
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 95
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Biological: PEG-interferon alfa-2b; Biological: GM-CSF; Drug: thalidomide	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine the response to PEG-interferon alfa-2b, sargramostim (GM-CSF), and thalidomide in patients with metastatic renal cell carcinoma.

Secondary

• Determine duration of response in patients treated with this regimen.

• Determine the tolerance to and toxicity of this regimen in these patients.

• Determine the median and progression-free survival of patients treated with this regimen.

OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1 and 8, sargramostim (GM-CSF) SC on days 1-10, and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma
• Study Start Date: Apr 1, 2002
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEG-Intron, BM-CSF and thalidomide	Biological: PEG-interferon alfa-2b; Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.; Biological: GM-CSF; GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle; Drug: thalidomide; 200mg daily by mouth

Outcome Measures

Primary Outcome Measures

1. Response Rate [while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year]

   To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide

Secondary Outcome Measures

1. Duration of Response [time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.]

2. Frequency of Adverse Events Assessed by NCI CTC Version 2 [From the first day of treatment until the end of treatment visit, an average of 6 months]

3. Progression-free Survival [From registration until diease progression or death, whichever comes first.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma

• Metastatic disease

• Measurable disease

• Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI

• Histologic confirmation required if measurable disease is confined to a solitary lesion

• The following are not considered measurable disease:

• Bone disease only

• Pleural or peritoneal metastases

• CNS lesions

• Irradiated lesions unless disease progression was documented after prior radiotherapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 mg/dL

• No decompensated liver disease

Renal

• Creatinine ≤ 2.0 mg/dL

Immunologic

• No known or suspected hypersensitivity to interferon alfa or to any excipient or vehicle included in the formulation or delivery system

• No history of autoimmune disease

• No autoimmune hepatitis

• No immunosuppressed transplantation recipients

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after study participation

• No pre-existing thyroid abnormalities for which thyroid function cannot be maintained in the normal range

• No severe psychiatric condition or disorder, including suicidal ideation or attempt

• No other active malignancy except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior immunotherapy

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• More than 4 weeks since prior radiotherapy

Surgery

• Not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina

Investigators

• Study Chair: Uzair B. Chaudhary, MD, Medical University of South Carolina
• Study Chair: Gustavo Leone, Medical University of South Carolina, Hollings Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT00090870
• Other Study ID Numbers: CDR0000378049; MUSC-100614; CELGENE-MUSC-100614; MUSC-HR-10423
• First Posted: Sep 8, 2004
• Last Update Posted: Jul 12, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by Medical University of South Carolina: stage IV renal cell cancer
• Additional relevant MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell; Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Thalidomide

Study Results

Participant Flow

Arm/Group Title	PEG-Intron, BM-CSF and Thalidomide
Arm/Group Description	PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days. GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle thalidomide: 200mg daily by mouth
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	PEG-Intron, BM-CSF and Thalidomide
Arm/Group Description	PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days. GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle thalidomide: 200mg daily by mouth
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 50%
>=65 years	5 50%
Sex: Female, Male (Count of Participants)
Female	1 10%
Male	9 90%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	10 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Response Rate
Description	To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide
Time Frame	while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year

Outcome Measure Data

Analysis Population Description

Data for this endpoint was not collected

Arm/Group Title	PEG-Intron, BM-CSF and Thalidomide
Arm/Group Description	PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days. GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle thalidomide: 200mg daily by mouth
Measure Participants	0

2. Secondary Outcome

Title	Duration of Response
Time Frame	time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.

Outcome Measure Data

Analysis Population Description

Data for this endpoint was not collected

Arm/Group Title	PEG-Intron, BM-CSF and Thalidomide
Arm/Group Description	PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days. GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle thalidomide: 200mg daily by mouth
Measure Participants	0

3. Secondary Outcome

Title	Frequency of Adverse Events Assessed by NCI CTC Version 2
Time Frame	From the first day of treatment until the end of treatment visit, an average of 6 months

Outcome Measure Data

Analysis Population Description

Data for this endpoint was not collected

Arm/Group Title	PEG-Intron, BM-CSF and Thalidomide
Arm/Group Description	PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days. GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle thalidomide: 200mg daily by mouth
Measure Participants	0

4. Secondary Outcome

Title	Progression-free Survival
Time Frame	From registration until diease progression or death, whichever comes first.

Outcome Measure Data

Analysis Population Description

Data for this endpoint was not collected

Arm/Group Title	PEG-Intron, BM-CSF and Thalidomide
Arm/Group Description	PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days. GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle thalidomide: 200mg daily by mouth
Measure Participants	0

Adverse Events

Time Frame	From day 1 of study treatment until end of study, for an average of 6 months
Adverse Event Reporting Description	Data for this endpoint was not collected
Arm/Group Title	PEG-Intron, BM-CSF and Thalidomide
Arm/Group Description	PEG-interferon alfa-2b: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days. GM-CSF: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle thalidomide: 200mg daily by mouth
All Cause Mortality
	PEG-Intron, BM-CSF and Thalidomide
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	PEG-Intron, BM-CSF and Thalidomide
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	PEG-Intron, BM-CSF and Thalidomide
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

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.