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

NCT00238329 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000445593P30CA022453WSU-C-2257WSU-HIC-120900M01-FB
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Response rate as measured scans and tumor measurements every 8 weeks

• Qualitative and quantitative toxicities at 30 days following study treatment

Secondary Outcomes (3)

• 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

Interventions

PEG-interferon alfa-2b BIOLOGICAL

thalidomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

peginterferon alfa-2b; Thalidomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ulka N. Vaishampayan, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 13, 2005
• Study Start: January 1, 2001
• Primary Completion: December 1, 2005
• Study Completion: June 1, 2007
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

US (1)