Biological Therapy in Treating Patients With Metastatic Melanoma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002786
• Date of registration: 01/11/1999
• Primary sponsor: Fred Hutchinson Cancer Research Center
• Public title: Biological Therapy in Treating Patients With Metastatic Melanoma
• Scientific title: PHASE I STUDY TO EVALUATE THE SAFETY OF CELLULAR ADOPTIVE IMMUNOTHERAPY USING GENETICALLY MODIFIED AND UNMODIFIED AUTOLOGOUS CD8+ TYROSINASE-SPECIFIC T CELLS FOR PATIENTS WITH METASTATIC MELANOMA
• Date of first enrolment: October 1995
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002786
• Study type: Interventional
• Study design: Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Cassian Yee, MD
• Affiliation: Fred Hutchinson Cancer Research Center

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histopathologically proven metastatic melanoma

- No CNS metastases

- HLA-A2 positive

- Bidimensionally measurable disease by palpation on clinical exam or radiographic
imaging (x-ray, CT scan, or MRI)

- Surgically accessible site for tumor cell procurement (skin, subcutaneous nodule, or
superficial node) and patient clinically eligible for such surgery

PATIENT CHARACTERISTICS:

Age

- 18 to 75

Performance status

- Karnofsky 80-100%

Life expectancy

- More than 16 weeks

Hematopoietic

- WBC greater than 4,000/mm^3

- Absolute neutrophil count greater than 2,000/mm^3

- Platelet count greater than 100,000/mm^3

- Hematocrit greater than 30%

Hepatic

- Bilirubin no greater than 1.6 mg/dL

- SGOT no greater than 150 IU (or no greater than 3 times normal)

- Prothrombin time no greater than 1.5 times control

Renal

- Creatinine no greater than 2.0 mg/dL

- Calcium no greater than 12 mg/dL

Cardiovascular

- No congestive heart failure

- No clinically significant hypotension

- No symptoms of coronary artery disease

- No arrhythmia on EKG requiring drug therapy

Pulmonary

- No severe chronic obstructive pulmonary disease

- FEV_1 at least 1.0 L

- DLCO at least 45% of predicted

Other

- No active infection or oral temperature greater than 38.2 degrees C within 72 hours
of study

- No systemic infection requiring chronic maintenance or suppressive therapy

- HIV negative

- No history of seizures

- No retinitis or choroiditis

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use adequate contraception

- Peripheral blood samples available weekly for 4 consecutive weeks

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 4 weeks since other prior immunotherapy

Chemotherapy

- 1 or 2 courses of cytoreductive chemotherapy allowed for bulky disease

- At least 4 weeks since prior standard or investigational chemotherapy

Endocrine therapy

- At least 4 weeks since prior steroid therapy

Radiotherapy

- At least 4 weeks since prior radiotherapy

Surgery

- Not specified

Other

- At least 4 weeks since other prior investigational drug therapy and recovered



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Melanoma (Skin)

Intervention(s)

Biological: aldesleukin

Biological: therapeutic tumor infiltrating lymphocytes

Secondary ID(s)

1017.01

CDR0000064846

FHCRC-1017.01

NCI-V96-0920

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)