Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	Other	STLMC-IMM-0002 NCI-V01-1657, NCT00016055

Objectives

1. Determine the safety of interleukin-12-primed activated T cells (12ATC) and temozolomide in patients with metastatic melanoma.
2. Determine the maximum tolerated dose of 12ATC in this patient population.
3. Determine the clinical response of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed metastatic melanoma
  • No ocular or mucosal melanoma



• Must meet one of the following criteria:
  • Failed standard or salvage therapy
  • Ineligible for standard therapy due to concurrent illness
  • Declined standard therapy



• Received at least 1 prior therapy for metastatic disease



• Brain metastasis as only site of metastatic disease allowed if there is documented evidence of progression after at least 1 prior treatment for metastases



• No leptomeningeal metastases



• At least 1 documented site of bidimensionally measurable disease by MRI or CT scan
  • Previously irradiated lesions not considered measurable unless documented disease progression after radiotherapy

Prior/Concurrent Therapy:

• See Disease Characteristics

Biologic therapy:

• More than 1 month since prior biologic therapy or immunotherapy

Chemotherapy:

• More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy:

• At least 4 weeks since prior steroid therapy or steroid-containing compounds
• At least 2 weeks since prior topical or inhaled steroids

Radiotherapy:

• See Disease Characteristics
• More than 1 month since prior radiotherapy, interstitial brachytherapy, or radiosurgery

Surgery:

• At least 1 week since prior surgery

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 3,000/mm³
• Absolute neutrophil count greater than 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 10 g/dL
• No coagulation disorder such as thrombophlebitis

Hepatic:

• Bilirubin less than 2.0 mg/dL
• AST and ALT less than 3 times upper limit of normal (ULN)
• Alkaline phosphatase less than 3 times ULN

Renal:

• Creatinine less than 1.5 times ULN
• BUN less than 1.5 times ULN

Cardiovascular:

• Ejection fraction at least 45%
• No active ischemia
• No unstable angina
• No uncontrolled congestive heart failure

Pulmonary:

• Normal pulmonary function tests within the past month
• FEV1 or FVC more than 65% predicted
• No uncontrolled pulmonary embolism

Gastrointestinal:

• No frequent vomiting
• No medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)

Other:

• No prolonged grade 4 myelosuppression from prior dacarbazine lasting more than 3 weeks
• No uncontrolled cortical dysfunction
• No other major medical illness (e.g., active systemic infection, autoimmune disease, or uncontrolled thyroid abnormality)
• No other malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix
• No significant psychiatric disease that would preclude study compliance
• No AIDS-related illness
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 9-18 patients will be accrued for this study.

Outcomes

Maximum tolerated dose at completion of study
Safety as measured by NCI common toxicity table at completion of study

Outline

This is a dose-escalation study of interleukin-12-primed activated T cells (12ATC).

Patients undergo leukopheresis on days 1-3 until adequate peripheral blood mononuclear cells (PBMC) are obtained. The PBMC are treated in vitro over 2 weeks with monoclonal antibody anti-CD3, interleukin-2, and interleukin-12 to form 12ATC.

Patients receive oral temozolomide on days 15-19 and 43-47 and 12ATC IV over 15-30 minutes on days 22, 25, 29, 32, 36, 39, 50, 53, 57, 60, 64, and 67 in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of 12ATC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 patients experience dose-limiting toxicity.

Patients are followed weekly for 2 weeks, every 3 months for 1 year, and then every 6 months for 2 years.

Trial Contact Information

Trial Lead Organizations

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

John Hanson, MD, Protocol chair		Ph: 414-649-5818; 800-252-2990 Email: jphanson@cancerrx.com

Registry Information
Official Title		Interleukin 12-Primed Activated T Cells As Therapy For Patients With Metastatic Melanoma (Phase I)
Trial Start Date		2000-11-30
Registered in ClinicalTrials.gov		NCT00016055
Date Submitted to PDQ		2001-03-02
Information Last Verified		2006-11-05

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