Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Melanoma
+8

+ Neoplasms
+ Neoplasms by Histologic Type
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2004
See protocol details

Summary

Principal SponsorJonsson Comprehensive Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleAn Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma 
NCT00081042
Principal SponsorJonsson Comprehensive Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Skin Diseases
Skin Neoplasms
Neuroectodermal Tumors
Nevi and Melanomas
Neuroendocrine Tumors
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Jonsson Comprehensive Cancer Center at UCLALos Angeles, United StatesSee the location

CompletedOne Study Center
;