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

An Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00081042
Enrollment
Unknown
Registered
2004-04-08
Start date
2004-02-29
Completion date
2010-01-31
Last updated
2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma, stage III melanoma, stage IV melanoma

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 works in treating patients with inoperable (unresectable) locally recurrent or metastatic melanoma.

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 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.

Interventions

DRUGpaclitaxel albumin-stabilized nanoparticle formulation

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Jonsson Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026