Stage IV MelanomaPhase 3NCT00003647
Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
A Phase 3 study testing allovectin-7, allovectin-7/dacarbazine and dacarbazine in people with Stage IV Melanoma and Stage III Melanoma, run by Vical at 44 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma
- What is being tested?
- allovectin-7, allovectin-7/dacarbazine and dacarbazine
- How many people
- Not given
- Where
- 44 sitesUnited States
- Study dates
- Jul 1998to Sep 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically confirmed stage III or IV melanoma 1 or more metastatic tumors for which surgery is not deemed to be a curative option
- Dacarbazine is indicated as first line chemotherapy
- At least 1 measurable tumor at least 1 cm2 but no greater than 100 cm2
- No history of brain metastases
--Prior/Concurrent Therapy--
- Biologic therapy: At least 4 weeks since prior biologic therapy
- Chemotherapy: See Disease Characteristics; No prior chemotherapy
- Endocrine therapy: No concurrent immunosuppressive drugs
- Radiotherapy: At least 4 weeks since prior radiotherapy
- Surgery: At least 2 weeks since prior major surgery
- Other: No other concurrent anticancer drug therapy or experimental therapy
--Patient Characteristics--
- Age: 18 and over
- Performance status: Karnofsky 80-100%
- Life expectancy: At least 24 weeks
- Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL
- Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal (ULN); PT/PTT normal; Albumin normal; LDH no greater than 2 times ULN
- Renal: Creatinine no greater than 2.0 mg/dL
- Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease
- Other: HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy within the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Franklin Square Hospital Center
Baltimore, Maryland, 21237
Billings Interhospital Oncology Project
Billings, Montana, 59101
Mid Dakota Clinic, P.C.
Bismarck, North Dakota, 58501
Cancer Care Center for Southern Indiana
Bloomington, Indiana, 47403
HemOnCare, P.C.
Brooklyn, New York, 11235
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
Mid-Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43222
Danville Hematology and Oncology, Inc.
Danville, Virginia, 24541
Georgia Cancer Specialists
Decatur, Georgia, 30033
Georgia Cancer Specialists, P.C.
East Point, Georgia, 30344
Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas
Encinitas, California, 92023
Arena Oncology Associates
Great Neck, New York, 11021
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
St. Francis Medical Center
Honolulu, Hawaii, 96817
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536-0093
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
Cancer Care Center
New Albany, Indiana, 47150
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
Louisiana State University School of Medicine
New Orleans, Louisiana, 70112-2822
Beth Israel Medical Center
New York, New York, 10003
Mount Sinai School of Medicine
New York, New York, 10029
Bergan Mercy Medical Center
Omaha, Nebraska, 68124
Lutheran General Hospital
Park Ridge, Illinois, 60068
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
Cancer Treatment Centers of America in Hampton Roads
Portsmouth, Virginia, 23704
North Memorial Health Care
Robbinsdale, Minnesota, 55422
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
Park Nicollet Clinic
Saint Louis Park, Minnesota, 55416
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Providence Hospital Cancer Center
Southfield, Michigan, 48075
St. Louis University Health Sciences Center
St Louis, Missouri, 63110-0250
Missouri Baptist Cancer Center
St Louis, Missouri, 63131
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
Toledo Clinic, Inc.
Toledo, Ohio, 43623
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
Oncology and Hematology Associates
Westwood, Kansas, 66205
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
About this study
Official title: Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma.
Read the detailed description
OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression by at least 2 months with no decrease in the rate of objective clinical response OR an improvement by at least 15% in the rate of objective clinical response with no decrease in the median time to disease progression in patients with stage III or IV melanoma receiving dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone.
II. Determine the benefits, risks, and side effects of these regimens in this patient population.
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease). Patients are randomized to one of two treatment arms.
Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10.
Patients with stable or responding disease may receive additional courses every 28 days.
Patients are followed every 4 months.
PROJECTED ACCRUAL:
A total of 280 patients (140 in each arm) will be accrued for this study.
- Conditions
- Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma
- Being tested
- allovectin-7, allovectin-7/dacarbazine, dacarbazine
- Keywords
- adult solid tumor, body system/site cancer, cancer, melanoma, recurrent melanoma, skin tumor, solid tumor, stage III melanoma, stage IV melanoma, stage, melanoma
- Medical subject headings
- Melanoma, Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allovectin-7Drug
allovectin-7/dacarbazineDrug
dacarbazineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2004 (estimated)
- Study startJul 1998
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Vical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Cherie Smith, Study chair, Vical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003647
- Sponsor's protocol ID
- CDR0000066736
- Other IDs
- VCL-1005-301
- Status last verified
- Jul 2008
- First submitted
- 1 Nov 1999
- Last updated
- 25 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00003647
- Acronym / sponsor ID
- CDR0000066736
- Conditions
- Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma
- Keywords
- adult solid tumor, body system/site cancer, cancer, melanoma, recurrent melanoma, skin tumor, solid tumor, stage III melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- VicalIndustry (pharma, biotech, devices)
- Study start
- Jul 1998
- Study completion
- Sep 2002 (actual)
- First posted
- 23 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma.
Detailed description
OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression by at least 2 months with no decrease in the rate of objective clinical response OR an improvement by at least 15% in the rate of objective clinical response with no decrease in the median time to disease progression in patients with stage III or IV melanoma receiving dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone.
II. Determine the benefits, risks, and side effects of these regimens in this patient population.
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease). Patients are randomized to one of two treatment arms.
Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10.
Patients with stable or responding disease may receive additional courses every 28 days.
Patients are followed every 4 months.
PROJECTED ACCRUAL:
A total of 280 patients (140 in each arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allovectin-7 | Drug | – |
| allovectin-7/dacarbazine | Drug | – |
| dacarbazine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cherie Smith study chair
Vical
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing allovectin-7, allovectin-7/dacarbazine and dacarbazine in people with Stage IV Melanoma and Stage III Melanoma, run by Vical at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2008.