Status:
UNKNOWN
Vaccine Therapy in Treating Patients With Stage IV Melanoma
Lead Sponsor:
Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I/II trial is studying the sid...
Detailed Description
OBJECTIVES: * Determine the safety and tolerability of vaccine therapy comprising autologous dendritic cells (DC) transfected with autologous polymerase chain reaction-amplified tumor RNA in patients...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed cutaneous melanoma\*
- Stage IV disease (i.e., distant metastasis)
- Not curable by surgical resection
- NOTE: \*Metastatic melanoma with an unknown primary tumor allowed provided ocular melanoma can be definitely excluded and origin from the skin is likely
- Unidimensionally or bidimensionally measurable disease by physical examination and/or noninvasive radiological procedures
- At least 1 measurable metastasis that has not been previously excised or biopsied
- Failed ≥ 1 standard chemotherapy or chemoimmunotherapy regimen (e.g., dacarbazine or cisplatin monotherapy)
- At least 1 metastatic lesion surgically accessible\* for excision or biopsy to obtain tumor material for RNA isolation\*\* NOTE: \*Surgically accessible metastatic lesion not required provided properly processed tumor material or isolated tumor RNA is available from a metastasis excised or biopsied within the past 6 months
- NOTE: \*\*Major surgery not allowed for the acquisition of metastatic material solely for RNA isolation
- No active CNS metastases by CT scan or MRI
- Previously treated CNS metastases (e.g., by excision of a single metastasis, gamma knife radiosurgery, or stereotactic radiotherapy) allowed provided there is no evidence of active CNS metastasis by CT scan or MRI
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- Karnofsky 60-100%
- Life expectancy
- At least 4 months
- Hematopoietic
- WBC \> 2,500/mm\^3
- Neutrophil count \> 1,000/mm\^3
- Lymphocyte count \> 700/mm\^3
- Platelet count \> 75,000/mm\^3
- Hemoglobin \> 9 g/dL
- No bleeding disorders
- Hepatic
- Bilirubin \< 2.0 mg/dL
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
- Renal
- Creatinine \< 2.5 mg/dL
- Cardiovascular
- No clinically significant heart disease
- Pulmonary
- No respiratory disease
- Immunologic
- HIV-1 or -2 negative
- Human T-cell lymphotropic virus type I negative
- No known hypersensitivity to dimethylsulfoxide
- No immunodeficiency disease
- No active systemic infection
- No active autoimmune disease (except vitiligo), including any of the following:
- Lupus erythematosus
- Scleroderma
- Rheumatoid arthritis (i.e., rheumatoid factor-positive arthritis with current or recent flare)
- Ankylosing spondylitis
- Autoimmune thyroiditis or uveitis
- Autoimmune hemolytic anemia
- Immune thrombocytopenic purpura
- Multiple sclerosis
- Inflammatory bowel disease
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile female patients must use effective contraception during and for ≥ 4 weeks after completion of study treatment
- Willing to undergo excision or biopsy of metastasis
- Willing to be hospitalized for ≥ 24 hours after each vaccination
- Medical condition stable
- No contraindication to leukapheresis
- No organic brain syndrome
- No significant psychiatric abnormality that would preclude study participation
- No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No other major serious illness
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- More than 4 weeks since prior systemic immunotherapy
- No systemic immunotherapy during and for 2 weeks after completion of study treatment
- Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior systemic chemotherapy
- No systemic chemotherapy during and for 2 weeks after completion of study treatment
- Endocrine therapy
- No systemic corticosteroids, including steroid-containing inhalers or chronic use of topical steroids over large areas of the body (if systemic effects are likely or obvious) during and for 2 weeks after completion of study treatment
- Radiotherapy
- See Disease Characteristics
- More than 2 weeks since prior radiotherapy
- No prior radiotherapy to the spleen
- Concurrent palliative radiotherapy to selected metastases for pain or local complications (e.g., compression) allowed
- Surgery
- See Disease Characteristics
- Recovered from prior surgery
- No prior splenectomy
- No prior organ allograft
- Concurrent palliative surgery to selected metastases for pain or local complications (e.g., compression) allowed
- Other
- Concurrent palliative hyperthermic therapy to selected metastases for pain or local complications (e.g., compression) allowed
- No concurrent participation in any other clinical trial
- No other systemic immunosuppressive agents (e.g., azathioprine or cyclosporine) during and for 2 weeks after completion of study treatment
- No other investigational drugs or paramedical substances during and for 2 weeks after completion of study treatment
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00126685
Start Date
April 1 2005
Last Update
September 17 2013
Active Locations (1)
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1
Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen
Erlangen, Germany, D-91052