PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Melanoma Melanoma (Skin) |
Biological: PEG-interferon alfa-2b Drug: thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma |
- Response rate as measured scans and tumor measurements every 8 weeks [ Designated as safety issue: No ]
- Qualitative and quantitative toxicities at 30 days following study treatment [ Designated as safety issue: Yes ]
- Progression-free survival by standard life table and Kaplan-Meier [ Designated as safety issue: No ]
- Overall survival by standard life table and Kaplan-Meier [ Designated as safety issue: No ]
- Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks [ Designated as safety issue: No ]
| Estimated Enrollment: | 32 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | June 2007 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Principal Investigator: | Ulka N. Vaishampayan, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00238329 History of Changes |
| Other Study ID Numbers: | CDR0000445593, P30CA022453, WSU-C-2257, WSU-HIC-120900M01-FB |
| Study First Received: | October 12, 2005 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Barbara Ann Karmanos Cancer Institute:
|
recurrent melanoma stage IV melanoma ciliary body and choroid melanoma, medium/large size |
extraocular extension melanoma iris melanoma recurrent intraocular melanoma |
Additional relevant MeSH terms:
|
Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Eye Neoplasms Neoplasms by Site Eye Diseases Uveal Diseases Interferon-alpha Interferon Alfa-2a |
Interferon Alfa-2b Interferons Peginterferon alfa-2b Reaferon Thalidomide Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013