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PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma

Primary Purpose

Intraocular Melanoma, Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PEG-interferon alfa-2b
thalidomide
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraocular Melanoma focused on measuring recurrent melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, recurrent intraocular melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma, including any of the following: Cutaneous melanoma Ocular melanoma Mucosal melanoma Unidentified primary tumor Recurrent or metastatic disease Bidimensionally measurable or evaluable disease Brain metastases allowed provided disease is stable for ≥ 6 weeks after prior radiotherapy PATIENT CHARACTERISTICS: Age 18 and over Performance status SWOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 2 times upper limit of normal (ULN) SGOT ≤ 2 times ULN Renal Creatinine ≤ 2 mg/dL Cardiovascular None of the following conditions within the past 3 months: Congestive heart failure Second- or third-degree heart block Myocardial infarction Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix No concurrent blood, sperm, or ova donation PRIOR CONCURRENT THERAPY: Biologic therapy Prior biologic therapy (e.g., interferon) allowed Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 28 days since prior radiotherapy Surgery At least 28 days since prior surgery Other No more than 2 prior systemic treatment regimens for metastatic malignant melanoma

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute

Outcomes

Primary Outcome Measures

Response rate as measured scans and tumor measurements every 8 weeks
Qualitative and quantitative toxicities at 30 days following study treatment

Secondary Outcome Measures

Progression-free survival by standard life table and Kaplan-Meier
Overall survival by standard life table and Kaplan-Meier
Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks

Full Information

First Posted
October 12, 2005
Last Updated
April 5, 2013
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00238329
Brief Title
PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma
Official Title
Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
June 2007 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop tumor cells from growing. PEG-interferon alfa-2b and thalidomide may also stop the growth of melanoma by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with thalidomide may be an effective treatment for melanoma. PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with thalidomide works in treating patients with recurrent or metastatic melanoma.
Detailed Description
OBJECTIVES: Determine the response rate in patients with recurrent or metastatic malignant melanoma treated with PEG-interferon alfa-2b and thalidomide. Determine the quantitative and qualitative toxic effects of this regimen in these patients. Determine progression-free and overall survival of patients treated with this regimen. OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly and oral thalidomide once daily. Treatment continues for at least 2 weeks but no more than 8 months in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive PEG-interferon alfa-2b and thalidomide for 2 months beyond documentation of CR. PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 14-38 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Melanoma, Melanoma (Skin)
Keywords
recurrent melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, recurrent intraocular melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
PEG-interferon alfa-2b
Intervention Type
Drug
Intervention Name(s)
thalidomide
Primary Outcome Measure Information:
Title
Response rate as measured scans and tumor measurements every 8 weeks
Title
Qualitative and quantitative toxicities at 30 days following study treatment
Secondary Outcome Measure Information:
Title
Progression-free survival by standard life table and Kaplan-Meier
Title
Overall survival by standard life table and Kaplan-Meier
Title
Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma, including any of the following: Cutaneous melanoma Ocular melanoma Mucosal melanoma Unidentified primary tumor Recurrent or metastatic disease Bidimensionally measurable or evaluable disease Brain metastases allowed provided disease is stable for ≥ 6 weeks after prior radiotherapy PATIENT CHARACTERISTICS: Age 18 and over Performance status SWOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 2 times upper limit of normal (ULN) SGOT ≤ 2 times ULN Renal Creatinine ≤ 2 mg/dL Cardiovascular None of the following conditions within the past 3 months: Congestive heart failure Second- or third-degree heart block Myocardial infarction Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix No concurrent blood, sperm, or ova donation PRIOR CONCURRENT THERAPY: Biologic therapy Prior biologic therapy (e.g., interferon) allowed Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 28 days since prior radiotherapy Surgery At least 28 days since prior surgery Other No more than 2 prior systemic treatment regimens for metastatic malignant melanoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulka N. Vaishampayan, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States

12. IPD Sharing Statement

Learn more about this trial

PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma

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