Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers

NCT00074308 | Completed Phase 1 Results

• 3 other identifiers: NCI-2012-0256403903CDR0000343804
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial to study the effectiveness of combining imatinib mesylate with bevacizumab in treating patients who have advanced melanoma or other metastatic or unresectable cancer. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Combining imatinib mesylate with bevacizumab may kill more tumor cells

Conditions

Recurrent Melanoma; Stage III Melanoma; Stage IV Melanoma; Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

• MTD, Defined as One Dose Level Below the Dose That Induced DLT in at Least One Third of Patients at a Dose Level, Graded According to NCI CTCAE Version 3.0 (Phase I)

  Up to 28 days

• Progression-free Survival at 16 Weeks (Phase II)

  Progression Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  16 weeks

Secondary Outcomes (2)

• Response Rate at 8 Weeks, Evaluated Using RECIST (Phase II)

  8 weeks

• Overall Survival (Phase II)

  Up to 6 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: imatinib mesylate; Biological: bevacizumab; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

imatinib mesylate DRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec

Arm I

bevacizumab BIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF

Arm I

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of 1 of the following:
• Metastatic or unresectable malignancy for which standard curative or palliative measures do not exist or are no longer effective (phase I) (phase I study closed to accrual as of 8/23/04)
• Melanoma (phase I and II)
• Measurable disease (phase II)
• No history or clinical evidence of CNS disease, including primary brain tumor or brain metastases
• Performance status - ECOG 0-1
• More than 3 months
• WBC at least 3,000/mm\^3
• Absolute granulocyte count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• No history of bleeding diathesis or coagulopathy
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST and ALT no greater than 2.5 times ULN
• INR no greater than 1.5
• APTT normal

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Imatinib Mesylate; Bevacizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Jane Daly
• Organization: Abramson Cancer Center of the University of Pennsylvania

jane@mail.med.upenn.edu

215-662-2812

Study Officials

• Keith Flaherty

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2003
• First Posted: December 11, 2003
• Study Start: October 1, 2003
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 20, 2018
• Results First Posted: January 16, 2018

Record last verified: 2018-05

Locations

US (1)