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Interleukin 12-Primed Activated T Cells As Therapy For Patients With Metastatic Melanoma (Phase I)

Phase 1
18 Years
Open (Enrolling)
Melanoma (Skin)

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Trial Information

Interleukin 12-Primed Activated T Cells As Therapy For Patients With Metastatic Melanoma (Phase I)


- 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.

Inclusion Criteria


- 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


- No prolonged grade 4 myelosuppression from prior dacarbazine lasting more than 3

- 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


- At least 1 week since prior surgery

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose at completion of study

Safety Issue:


Principal Investigator

John P. Hanson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Luke's Medical Center


United States: Federal Government

Study ID:




Start Date:

November 2000

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma



Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center Milwaukee, Wisconsin  53201-2901