Temsirolimus and Bevacizumab in Treating Patients With Stage III or Stage IV Malignant Melanoma

Completed · Phase 2

Conditions studied: Recurrent Melanoma, Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma, Stage IV Skin Melanoma

In brief

This phase II trial is studying how well giving temsirolimus together with bevacizumab works in treating patients with stage III or stage IV malignant melanoma. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of malignant melanoma by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may kill more tumor cells.

Key facts

Study ID

NCT00397982

Run by

National Cancer Institute (NCI)

People needed

17

Starts

2008-01-01

Expected to finish

2013-07-01

Last updated by the study team

2017-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed melanoma
• Stage III or IV disease
• Recurrent disease allowed
• Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm with conventional techniques OR ≥ 10 mm with spiral CT scan
• Tumor lesions in previously irradiated areas are not considered measurable disease
• Prior brain metastases allowed provided all of the following criteria are met:
• No more than a total of 5 brain metastases
• All metastases are no more than 2.5 cm
• Surgically resected or have been treated with gamma-knife or stereotactic radiosurgery
• More than 30 days since prior disease progression
• More than 30 days since prior steroids for managing brain metastases
• Concurrent steroids for other reasons allowed provided the dose is < that required for managing brain metastases
• Disease accessible for core needle biopsy, incisional biopsy, and/or surgical resection and meets one of the following criteria:
• One large tumor deposit ≥ 5 cm³ from which biopsies can be harvested multiple times
• Multiple deposits that can be biopsied or excised individually on different dates, measured as follows:
• One lesion ≥ 5 cm\^3
• Two lesions ≥ 3 cm\^3
• Three lesions ≥ 2 cm\^3
• ECOG performance status 0-1
• Weight ≥ 110 pounds (without clothes)
• WBC ≥ 3,000 mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin normal
• AST and ALT ≤ 2.5 times upper limit of normal

You may not qualify if…

• Participants who have received these medications or treatments at any time ≤ 4 weeks of registration:
• Chemotherapy
• Radiotherapy to non-target lesions and lesions that are not to be biopsied. Prior radiotherapy to target lesions or lesions to be biopsied/resected is not permitted
• Immunotherapy
• Cytokine therapy
• Investigational reagents
• Invasive procedures defined as follows:
• Major surgical procedure, open biopsy or significant traumatic injury
• Anticipation of need for non-study related surgical procedures from registration until Cycle 26 (One year).
• Enzyme-inducing antiepileptic drugs (EIAEDs) or any other CYP3A4 inducer (Appendix C).
• OR Participants who have not recovered from adverse events resulting from the administration of these agents/procedures > 4 weeks prior to registration.
• Participants who have received nitrosureas or mitomycin C ≤ 6 weeks of registration.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779 or bevacizumab, or with known hypersensitivity to Chinese hamster ovary cell products (t-PA) or other recombinant human antibodies (e.g., Remicade®).
• Participants who have previously received CCI-779, rapamycin, bevacizumab, or systemic therapies targeted primarily to VEGF, VEGF receptors, or to mTOR inhibition.
• Participants who have experienced any of the following ≤ 4 weeks prior to registration:
• Uncontrolled intercurrent illness
• Infection, CTCAE3 grade 3 or 4 (either ongoing, chronic, or active infection)
• Abdominal fistula
• Gastrointestinal perforation
• Intra-abdominal abscess
• Serious or non-healing wound
• Serious or non-healing ulcer
• Serious or non-healing bone fracture.
• Potential subjects with clinically significant cardiovascular disease
• Recent history (defined as ≤ 6 months of registration) of thromboembolic events including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial ischemia, myocardial infarction (MI)

Where it is running

• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Virginia Cancer Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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