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

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
paclitaxel albumin-stabilized nanoparticle formulation
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage III melanoma, stage IV melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 7, 2004
Last Updated
December 18, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00081042
Brief Title
ABI-007 in Treating Patients With Inoperable Locally Recurrent or Metastatic Melanoma
Official Title
An Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
recurrent melanoma, stage III melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paclitaxel albumin-stabilized nanoparticle formulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni Ribas, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19877111
Citation
Hersh EM, O'Day SJ, Ribas A, Samlowski WE, Gordon MS, Shechter DE, Clawson AA, Gonzalez R. A phase 2 clinical trial of nab-paclitaxel in previously treated and chemotherapy-naive patients with metastatic melanoma. Cancer. 2010 Jan 1;116(1):155-63. doi: 10.1002/cncr.24720.
Results Reference
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ABI-007 in Treating Patients With Inoperable Locally Recurrent or Metastatic Melanoma

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