Interferon Alfa and Thalidomide in Treating Patients With Stage IV Melanoma
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Purpose
RATIONALE: Interferon alfa may interfere with the growth of cancer cells and slow the growth of the tumor. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining interferon alfa with thalidomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with thalidomide in treating patients who have stage IV melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: recombinant interferon alfa Drug: thalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Evaluation of Interferon Alpha-2b and Thalidomide in Patients With Disseminated Malignant Melanoma, Phase II |
| Study Start Date: | November 2001 |
OBJECTIVES:
- Determine the 6-month progression-free survival rate in patients with stage IV melanoma treated with interferon alfa and thalidomide.
- Determine the confirmed and unconfirmed complete and partial response rates in patients with measurable disease treated with this regimen.
- Determine the quantitative and qualitative toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive interferon alfa subcutaneously twice daily and oral thalidomide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses after documentation of CR.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV malignant melanoma
- Surgically incurable disease
- Measurable or evaluable disease
No brain metastases by CT scan or MRI
- Prior brain metastases allowed only if completely resected and treated with whole brain radiotherapy
Must have received 1, and only 1, prior systemic therapy for metastatic disease
- Chemotherapy, biologic/immunotherapy, hormonal therapy, or combination therapy
PATIENT CHARACTERISTICS:
Age:
- Adult
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 75,000/mm^3
Hepatic:
- SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN)
- Bilirubin no greater than ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 methods of effective contraception 4 weeks before, during, and for 4 weeks after study
- HIV negative
- No AIDS or HIV-1-associated complex
- No other serious illness
- No serious active infections
- No sensory neuropathy greater than grade 1
- No prior seizures or concurrent potential risk factors for the development of seizures
- No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 21 days since prior biologic therapy or immunotherapy in the adjuvant or metastatic setting and recovered
- No concurrent filgrastim (G-CSF)
- No other concurrent biologic therapy
Chemotherapy:
- See Disease Characteristics
- At least 21 days since prior chemotherapy in the adjuvant or metastatic setting and recovered
- No concurrent chemotherapy
Endocrine therapy:
- See Disease Characteristics
- At least 21 days since prior hormonal therapy in the adjuvant or metastatic setting and recovered
- No concurrent hormonal therapy
- No concurrent systemic steroids (including creams)
Radiotherapy:
- See Disease Characteristics
- At least 21 days since prior radiotherapy and recovered
- Prior radiotherapy to all known sites of disease allowed if there is objective evidence of progression
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- At least 21 days since prior surgery for primary or metastatic disease and recovered
- No concurrent surgery
Other:
- At least 21 days since prior systemic therapy or combination regimen for metastatic disease and recovered
- At least 21 days since prior adjuvant isolation limb perfusion therapy and recovered
- No other concurrent therapy
- No other concurrent investigational drugs
- No concurrent immunosuppressive medications
- Concurrent antihistamines allowed if no alternative medication available
Contacts and Locations
Show 94 Study Locations| Study Chair: | Laura F. Hutchins, MD | University of Arkansas |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00026520 History of Changes |
| Other Study ID Numbers: | CDR0000069046, SWOG-S0026 |
| Study First Received: | November 9, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV melanoma recurrent melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Interferon-alpha Interferon Alfa-2a Interferons 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 Antineoplastic Agents Immunosuppressive Agents Leprostatic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 22, 2013