Vaccine Therapy for Patients With Stage IV Melanoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00052156 |
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Recruitment Status : Unknown
Verified April 2005 by CancerVax Corporation.
Recruitment status was: Active, not recruiting
First Posted : January 24, 2003
Last Update Posted : June 24, 2005
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Sponsor:
CancerVax Corporation
Information provided by:
CancerVax Corporation
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Brief Summary:
This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Malignant Melanoma | Biological: CancerVax vaccine (CANVAXIN) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 670 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Plus BCG Versus Placebo Plus BCG as a Post-Surgical Treatment for Stage IV Melanoma |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Melanoma
U.S. FDA Resources
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
- Must have Stage IV melanoma
- Must have had all clinically-detectable disease surgically removed
- Cannot be taking any medications, or undergoing any therapies which compromise the functioning of your immune system (ie. Some corticosteroids, and certain types of radiation therapy)
- Cannot have HIV or Hepatitis A, B, or C
Information from the National Library of Medicine
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): NCT00052156
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Sponsors and Collaborators
CancerVax Corporation
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00052156 History of Changes |
| Obsolete Identifiers: | NCT00003722 |
| Other Study ID Numbers: |
CV-MMAIT-4-001 JWCI-MC-4-001 |
| First Posted: | January 24, 2003 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | April 2005 |
Additional relevant MeSH terms:
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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 Vaccines Immunologic Factors Physiological Effects of Drugs |