Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00016055
Recruitment Status : Unknown
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of biological therapy combined with temozolomide in treating patients who have metastatic melanoma.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: lymphokine-activated killer cells Drug: temozolomide Phase 1

Detailed Description:


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

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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Primary Purpose: Treatment
Official Title: Interleukin 12-Primed Activated T Cells As Therapy For Patients With Metastatic Melanoma (Phase I)
Study Start Date : November 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Primary Outcome Measures :
  1. Maximum tolerated dose at completion of study
  2. Safety as measured by NCI common toxicity table at completion of study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months


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


  • 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


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


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


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


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


  • 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


  • See Disease Characteristics

Biologic therapy:

  • More than 1 month since prior biologic therapy or immunotherapy


  • 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


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


  • At least 1 week since prior surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00016055

United States, Wisconsin
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
St. Luke's Medical Center
Study Chair: John P. Hanson, MD St. Luke's Medical Center Identifier: NCT00016055     History of Changes
Other Study ID Numbers: CDR0000068590
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: November 2006

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents