Status:
COMPLETED
ABI-007 in Treating Patients With Inoperable Locally Recurrent or Metastatic Melanoma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
OBJECTIVES: Primary * Determine the antitumor activity of ABI-007 in patients with inoperable locally recurrent or metastatic melanoma. * Determine the safety and tolerability of this drug in these ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00081042
Start Date
February 1 2004
End Date
January 1 2010
Last Update
December 19 2013
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781