ABI-007 in Treating Patients With Inoperable Locally Recurrent or Metastatic Melanoma

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well ABI-007 works in treating patients with inoperable (unresectable) locally recurrent or metastatic melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed melanoma

• Inoperable locally recurrent or metastatic disease

• Measurable disease

• No lytic or blastic bone metastasis as only evidence of metastasis

• Prior radiotherapy to a target lesion allowed provided there has been clear progression of disease since completion of radiotherapy

• No active brain metastasis, including leptomeningeal involvement

• Prior brain metastasis allowed provided the disease is in complete remission for at least 1 month after therapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• More than 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9 g/dL

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis)

• Bilirubin ≤ 1.5 mg/dL

Renal

• Creatinine ≤ 1.5 mg/dL

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception 1 month before and during study participation

• No pre-existing peripheral neuropathy ≥ grade 2

• No prior allergy or hypersensitivity to study drug

• No concurrent clinically significant illness

• No other concurrent active malignancy

• No serious medical risk factors involving any of the major organ systems that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Recovered from prior chemotherapy

• More than 4 weeks since prior cytotoxic chemotherapy

• At least 3 weeks since prior anthracyclines

• No concurrent taxane or anthracyclines

• No concurrent doxorubicin

Endocrine therapy

• No concurrent steroids except as needed for hypersensitivity to study drug

Radiotherapy

• See Disease Characteristics

• Concurrent radiotherapy to a symptomatic non-target lesion (including recurrent or new brain metastases that develop during study participation) allowed

Surgery

• Not specified

Other

• More than 4 weeks since prior investigational drugs and recovered

• No other concurrent anticancer therapy

• No concurrent participation in another clinical study

• No other concurrent investigational therapies

• No concurrent ritonavir, saquinavir, indinavir, or nelfinavir