Vaccine Therapy in Treating Patients With Stage IV Melanoma

NCT00126685 | Unknown Phase 1

• 4 other identifiers: CDR0000435933ERLANGEN-DERMA-ER-DC-07EU-20513ARGOS-ERLANGEN-DERMA-DC-07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 side effects of vaccine therapy and to see how well it works in treating patients with stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (6)

• Safety

• Immunogenicity

• Objective tumor response

• Time to disease progression

• Progression-free interval

• Overall survival

Interventions

autologous tumor cell vaccine BIOLOGICAL

therapeutic autologous dendritic cells BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen: lead

Study Sites (1)

Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen

Erlangen, D-91052, Germany

Location

MeSH Terms

Conditions

Melanoma

Interventions

FANG vaccine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gerold Schuler

  Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 3, 2005
• First Posted: August 4, 2005
• Study Start: April 1, 2005
• Last Updated: September 17, 2013

Record last verified: 2007-06

Locations

DE (1)