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


Phase 2
18 Years
N/A
Not Enrolling
Both
Intraocular Melanoma, Melanoma (Skin)

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate as measured scans and tumor measurements every 8 weeks

Safety Issue:

No

Principal Investigator

Ulka N. Vaishampayan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000445593

NCT ID:

NCT00238329

Start Date:

January 2001

Completion Date:

June 2007

Related Keywords:

  • Intraocular Melanoma
  • Melanoma (Skin)
  • recurrent melanoma
  • stage IV melanoma
  • ciliary body and choroid melanoma, medium/large size
  • extraocular extension melanoma
  • iris melanoma
  • recurrent intraocular melanoma
  • Melanoma
  • Uveal Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201