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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238329
• Other study ID #: CDR0000445593
• Secondary ID: P30CA022453WSU-C
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2005
• Last updated: April 5, 2013
• Start date: January 2001
• Est. completion date: June 2007

Study information

• Verified date: April 2013
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2007
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraocular Melanoma
• Melanoma
• Melanoma (Skin)
• Uveal Neoplasms

Intervention

Biological:
• PEG-interferon alfa-2b

Drug:
• thalidomide

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as measured scans and tumor measurements every 8 weeks			No
Primary	Qualitative and quantitative toxicities at 30 days following study treatment			Yes
Secondary	Progression-free survival by standard life table and Kaplan-Meier			No
Secondary	Overall survival by standard life table and Kaplan-Meier			No
Secondary	Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks			No