Clinical trial NCT00238329: PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma
Official title: Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-10-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Response rate as measured scans and tumor measurements every 8 weeks
measure: Qualitative and quantitative toxicities at 30 days following study treatment
Secondary outcomes:
measure: Progression-free survival by standard life table and Kaplan-Meier
measure: Overall survival by standard life table and Kaplan-Meier
measure: Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Ulka N. Vaishampayan, MD
role: PRINCIPAL_INVESTIGATOR
References: