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

Condition(s) targeted: Intraocular Melanoma; Melanoma (Skin)

Intervention: PEG-interferon alfa-2b (Drug); thalidomide (Drug); antiangiogenesis therapy (Procedure); interferon therapy (Procedure); non-specific immune-modulator therapy (Procedure)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Barbara Ann Karmanos Cancer Institute

Official(s) and/or principal investigator(s):
Ulka N. Vaishampayan, MD, Principal Investigator, Affiliation: Barbara Ann Karmanos Cancer Institute

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.

Official title: Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma

Study design: Treatment, Open Label

Primary outcome:

Response rate as measured scans and tumor measurements every 8 weeks

Qualitative and quantitative toxicities at 30 days following study treatment

Secondary outcome:

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2001
Last updated: December 25, 2007