Interferon Beta in Treating Patients With Metastatic Cutaneous Melanoma or Ocular Melanoma

NCT00085306 | Completed Phase 2 DMC

• 3 other identifiers: CASE1604P30CA043703CCF-4049
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Interferon beta may interfere with the growth of tumor cells. PURPOSE: This phase II trial is studying how well interferon beta works in treating patients with metastatic cutaneous (skin) melanoma or ocular (eye) melanoma.

Conditions

Stage IV Melanoma; Recurrent Melanoma

Keywords

recurrent melanoma; stage IV melanoma; iris melanoma; ciliary body and choroid melanoma, medium/large size; extraocular extension melanoma; recurrent intraocular melanoma

Outcome Measures

Primary Outcomes (1)

• Objective clinical response rate to IFN-B the maximum tolerated dose as measured by a CTC Grade III hematologic or a Grade IV granulocyte toxicity which persists > 3 days at 1 week after each course

Study Arms (1)

Recombinant interferon beta

EXPERIMENTAL

Biological: recombinant interferon beta

Interventions

recombinant interferon beta BIOLOGICAL

recombinant interferon beta

Recombinant interferon beta

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma * Cutaneous or ocular disease * Measurable disease * No active unstable CNS metastases by neurologic exam AND CT scan or MRI * Irradiated and/or resected CNS lesions allowed if there is no evidence of disease by head MRI or CT scan for \> 6 months after surgery and/or radiotherapy * Patients with cutaneous metastases and previously irradiated and/or resected CNS metastases are eligible if the CNS metastases are controlled and do not require dexamethasone PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 (0-2 for patients with cutaneous metastases) Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,200/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.5 g/dL Hepatic * Bilirubin ≤ 1.5 mg/dL * AST ≤ 3.0 times normal * Alkaline phosphatase ≤ 2.5 times normal (10 times normal if due to bone metastases) * Hepatitis B surface antigen negative Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * No serious cardiac arrhythmia requiring treatment * No congestive heart failure * No angina pectoris * No New York Heart Association class II-IV heart disease * No other severe cardiovascular disease Other * HIV negative * No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the uterine cervix * No history of seizure disorder * No severe psychiatric disorder * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * More than 12 months since prior adjuvant interferon alfa-2 (IFNα-2) therapy * More than 30 days since prior IFNα-2 therapy for metastatic disease (6 months for patients with cutaneous metastases) * No more than 1 prior systemic regimen (chemotherapy or biologic) for metastatic disease (3 regimens for patients with cutaneous metastases) Chemotherapy * See Biologic therapy * No concurrent chemotherapy Endocrine therapy * See Disease Characteristics * Concurrent replacement therapy with physiologic doses of corticosteroids allowed * No concurrent dexamethasone or other steroidal antiemetics or anti-inflammatories * No other concurrent hormonal agents except steroids administered for preexisting adrenal failure or hormones administered for non-disease-related conditions (e.g., insulin for diabetes) Radiotherapy * See Disease Characteristics * More than 28 days since prior radiotherapy and recovered * No concurrent palliative radiotherapy Surgery * See Disease Characteristics * No prior organ allograft * More than 28 days since prior major surgery requiring general anesthesia Other * More than 28 days since prior antibiotics for local or systemic infection * No concurrent aspirin * No concurrent barbiturates * No other concurrent investigational agents

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Melanoma; Uveal Melanoma

Interventions

Interferon-beta

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ernest C. Borden, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: April 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: October 2, 2015

Record last verified: 2015-10

Locations

US (1)