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ABT-510 in Treating Patients With Metastatic Melanoma

Primary Purpose

Melanoma (Skin)

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

ABT-510

immunoenzyme technique

immunohistochemistry staining method

laboratory biomarker analysis

pharmacological study

biopsy

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

Histologically confirmed malignant melanoma
- Stage IV disease
- No known potentially curative standard therapy that exists or is proven capable of extending life expectancy
Measurable disease
No history of or current CNS metastases
- MRI of the brain to confirm absence of CNS metastases within the past 28 days is required
No known, presently active carcinomatous meningitis

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy ≥ 6 months
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
AST ≤ 3 times ULN
Creatinine ≤ 2.5 times ULN
Hemoglobin ≥ 9.0 g/dL
Prothrombin time normal
Willing to return to Mayo Clinic Rochester, Jacksonville or Scottsdale for follow-up
Must be able to self-administer or has a caregiver who can reliably administer subcutaneous injections
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No uncontrolled or current infection
No New York Heart Association class III-IV heart disease
No recent history of (i.e., ≤ 12 weeks from study day 1) or current cancer-related bleeding event (e.g., hemoptysis)
No recent history of (within the past 4 weeks) or current noncancer-related clinically significant bleeding event
No uncontrolled hypertension
No history of stroke or other CNS bleeding events (e.g., aneurysms)

PRIOR CONCURRENT THERAPY:

At least 4 weeks since prior chemotherapy and recovered (6 weeks for mitomycin C or nitrosoureas)
At least 4 weeks since prior immunotherapy, biologic therapy, radiotherapy, or surgery
No concurrent anticoagulation therapy or antiplatelet therapy
No other concurrent antineoplastic agents (e.g., cytotoxic chemotherapy, immunotherapy, radiotherapy, or investigational therapy) except local radiotherapy for supportive reasons involving a small radiation field

Sites / Locations

Outcomes

Primary Outcome Measures

18-week progression-free survival rate

Secondary Outcome Measures

Objective response rate as defined by RECIST criteria

Overall survival time

Frequency of NK-cells, T-cells, and B-cells before the start of the first 5 courses of treatment

Full Information

NCT ID

NCT00602199

First Posted

January 11, 2008

Last Updated

May 13, 2011

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00602199

Brief Title

ABT-510 in Treating Patients With Metastatic Melanoma

Official Title

A Phase II Study of Anti-angiogenesis Therapy for Metastatic Melanoma Using ABT-510

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

November 2004 (undefined)

Primary Completion Date

June 2005 (Actual)

Study Completion Date

June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

RATIONALE: ABT-510 may stop the growth of melanoma by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well giving ABT-510 works in treating patients with metastatic melanoma.

Detailed Description

OBJECTIVES: Examine the safety profile of ABT-510 in patients with metastatic malignant melanoma. Examine the antitumor activity (i.e., time to progression and response rates) in patients treated with ABT-510. Determine the pharmacodynamic effects of ABT-510 and its potential impact on immune cell function in these patients. OUTLINE: Patients receive ABT-510 subcutaneously twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline, before treatment on day 1 of cycles 2 and 3, and then every other course thereafter for pharmacological and ancillary studies. Samples are evaluated for EC enumeration, expression profiling, circulating tumor cell quantification, analysis of T-cell functions (i.e., immunophenotyping for NK-, T- and B-cell phenotypes as well as ELISPOT analysis against common environmental pathogens and T cell spectratyping), and angiogenesis bioassays. Patients also undergo ultrasound-guided core tumor biopsies for histological analysis of microvascular density (CD38 and von Willebrand Factor immunohistochemistry) at baseline and before treatment on day 1 of courses 3 and 5. After completion of study treatment, patients are followed every 3 months for up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma (Skin)

Keywords

stage IV melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ABT-510

Intervention Type

Other

Intervention Name(s)

immunoenzyme technique

Intervention Type

Other

Intervention Name(s)

immunohistochemistry staining method

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Type

Other

Intervention Name(s)

pharmacological study

Intervention Type

Procedure

Intervention Name(s)

biopsy

Primary Outcome Measure Information:

Title

18-week progression-free survival rate

Secondary Outcome Measure Information:

Title

Objective response rate as defined by RECIST criteria

Title

Overall survival time

Title

Frequency of NK-cells, T-cells, and B-cells before the start of the first 5 courses of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma Stage IV disease No known potentially curative standard therapy that exists or is proven capable of extending life expectancy Measurable disease No history of or current CNS metastases MRI of the brain to confirm absence of CNS metastases within the past 28 days is required No known, presently active carcinomatous meningitis PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy ≥ 6 months ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Alkaline phosphatase ≤ 3 times upper limit of normal (ULN) AST ≤ 3 times ULN Creatinine ≤ 2.5 times ULN Hemoglobin ≥ 9.0 g/dL Prothrombin time normal Willing to return to Mayo Clinic Rochester, Jacksonville or Scottsdale for follow-up Must be able to self-administer or has a caregiver who can reliably administer subcutaneous injections Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled or current infection No New York Heart Association class III-IV heart disease No recent history of (i.e., ≤ 12 weeks from study day 1) or current cancer-related bleeding event (e.g., hemoptysis) No recent history of (within the past 4 weeks) or current noncancer-related clinically significant bleeding event No uncontrolled hypertension No history of stroke or other CNS bleeding events (e.g., aneurysms) PRIOR CONCURRENT THERAPY: At least 4 weeks since prior chemotherapy and recovered (6 weeks for mitomycin C or nitrosoureas) At least 4 weeks since prior immunotherapy, biologic therapy, radiotherapy, or surgery No concurrent anticoagulation therapy or antiplatelet therapy No other concurrent antineoplastic agents (e.g., cytotoxic chemotherapy, immunotherapy, radiotherapy, or investigational therapy) except local radiotherapy for supportive reasons involving a small radiation field

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Svetomir Markovic, MD, PhD

Organizational Affiliation

Mayo Clinic

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

17551310

Citation

Markovic SN, Suman VJ, Rao RA, Ingle JN, Kaur JS, Erickson LA, Pitot HC, Croghan GA, McWilliams RR, Merchan J, Kottschade LA, Nevala WK, Uhl CB, Allred J, Creagan ET. A phase II study of ABT-510 (thrombospondin-1 analog) for the treatment of metastatic melanoma. Am J Clin Oncol. 2007 Jun;30(3):303-9. doi: 10.1097/01.coc.0000256104.80089.35.

Results Reference

result

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ABT-510 in Treating Patients With Metastatic Melanoma

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