ABI-007 in Treating Patients With Inoperable Locally Recurrent or Metastatic Melanoma
This study is currently recruiting patients.
Sponsored by: |
Jonsson Comprehensive Cancer Center
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Information provided by: |
National Cancer Institute (NCI) |
Purpose
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: Phase II trial to study the effectiveness of ABI-007 in treating patients who have inoperable (unresectable) locally
recurrent or metastatic melanoma.
Condition
|
Treatment or Intervention |
Phase |
Recurrent Melanoma stage III melanoma Stage IV Melanoma
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Drug: ABI-007 Procedure: chemotherapy
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Phase II
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MedlinePlus related topics: Melanoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of ABI-007 in Patients With Inoperable Locally Recurrent or Metastatic Melanoma
Further Study Details:
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 patients.
Secondary
- Determine the time to disease progression, in terms of the rate and duration of response or stable disease, in patients treated
with this drug.
- Determine the survival of patients treated with this drug.
- Determine the effects of this drug on biomarkers of melanoma in these patients.
- Correlate biomarker levels with response in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment cohorts according to prior cytotoxic
chemotherapy (previously treated vs chemotherapy-naïve).
- Cohort I (previously treated): Patients receive ABI-007 IV over 30 minutes on days 1, 8, and 15.
- Cohort II (chemotherapy-naïve): Patients receive a higher dose of ABI-007 as in cohort I. In both cohorts, courses repeat
every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for 6 months and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 24-70 patients (12-35 per cohort) will be accrued for this study.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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
Performance status
Life expectancy
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
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
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
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
Location
and Contact
Information
California Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,
California,
90095-1781,
United States; Recruiting
Study chairs or principal investigators
Antoni Ribas, MD, Study Chair, Jonsson Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000358804; UCLA-0309060; ABI-CA014
Record last reviewed:
March 2004
Record first received:
April 7, 2004
ClinicalTrials.gov Identifier:
NCT00081042Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22