Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
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| ClinicalTrials.gov Identifier: NCT00085488 |
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Recruitment Status :
Completed
First Posted : June 11, 2004
Last Update Posted : February 2, 2015
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RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Melanoma (Skin) | Biological: autologous tumor cell vaccine Biological: therapeutic autologous dendritic cells | Phase 1 |
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and the maximum tolerated dose of autologous dendritic cells pulsed with autologous tumor cell lysate in patients with stage III or IV melanoma.
- Determine the safety and tolerability of this therapy in these patients.
Secondary
- Determine the immune response, in terms of the type and degree of T-cell proliferation and delayed-type hypersensitivity responses, in patients treated with this therapy.
OUTLINE: This is a dose-escalation, pilot study.
Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC) on days -9, 19, and 47. Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to sargramostim (GM-CSF), interleukin-4, and tumor necrosis factor alpha and pulsed with autologous tumor cell lysate. Patients receive autologous tumor cell lysate-pulsed DC IV over 5-10 minutes on days 0, 28, and 56.
Cohorts of 3-6 patients receive escalating doses of autologous tumor cell lysate-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of all patients experience dose-limiting toxicity.
Patients are followed at day 84 and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 3-20 months.
| Study Type : | Interventional (Clinical Trial) |
| Primary Purpose: | Treatment |
| Official Title: | En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma |
| Study Start Date : | February 2004 |
| Actual Primary Completion Date : | February 2006 |
| Actual Study Completion Date : | February 2006 |
- Ex Vivo Matured Dendritic Cell Therapy in Patients with Melanoma [ Time Frame: 2005-2006 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed melanoma
- Stage III (lymph node or in-transit metastases) or IV (systemic metastases) disease
- Patients with relapsed disease OR who failed prior immunotherapy or chemotherapy are eligible (but trial not restricted to relapsed or refractory disease)
- Tumor tissue available and properly stored for lysate preparation
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 75,000/mm^3
Hepatic
- AST ≤ 2 times upper limit of normal (ULN) (3 times ULN for liver metastases)
- Bilirubin ≤ 2 times ULN
- Hepatitis B surface antigen negative
- Hepatitis C negative
Renal
- Creatinine ≤ 2.0 times ULN
Immunologic
- No active infection
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No history of autoimmune disease, including any of the following:
- Inflammatory bowel disease
- Systemic lupus erythematosus
- Scleroderma
- Rheumatoid arthritis
- Multiple sclerosis
- No allergy to aminoglycosides or streptomycin
- HIV negative
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No significant comorbid illness
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 10 days since prior immunotherapy
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- At least 6 weeks since prior steroid therapy
- No concurrent corticosteroids
Radiotherapy
- At least 10 days since prior radiotherapy
- No concurrent radiotherapy
Surgery
- At least 10 days since prior surgery
- Prior diagnostic or palliative surgery allowed provided the patient has fully recovered
Other
- No concurrent immunosuppressive or potentially immunosuppressive therapy
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 ClinicalTrials.gov identifier (NCT number): NCT00085488
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Study Chair: | Christopher P. Tretter, MD | Norris Cotton Cancer Center |
| Responsible Party: | Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT00085488 |
| Other Study ID Numbers: |
CDR0000370802 DMS-9935 DMS-14862 |
| First Posted: | June 11, 2004 Key Record Dates |
| Last Update Posted: | February 2, 2015 |
| Last Verified: | October 2005 |
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recurrent melanoma stage III melanoma stage IV melanoma |
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Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |