Stage IV MelanomaPhase 2NCT00003646
Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
A Phase 2 study testing allovectin-7 in people with Stage IV Melanoma and Stage III Melanoma, run by Vical at 3 sites in United States.
Trial summary
RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment. 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
- How many people
- 78 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 1998to May 2002
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically confirmed melanoma; Stage III with locoregional disease, in transit metastasis, or nodal disease OR Stage IV metastatic disease in skin, subcutaneous tissue, lymph node(s), and/or lung
- At least 1 metastasis for which surgery is not deemed to be a curative option
- Relapsed from or has not responded to frontline chemotherapy or biotherapy
- At least 1 measurable tumor at least 1 cm by 1 cm, but less than 5 cm by 5 cm
- No history of brain metastases or visceral metastases other than lung metastases
--Prior/Concurrent Therapy--
- Biologic therapy: See Disease Characteristics; At least 4 weeks since prior biologic therapy
- Chemotherapy: See Disease Characteristics; At least 4 weeks since 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 any other experimental therapy
--Patient Characteristics--
- Age: 18 and over
- Performance status: Karnofsky 80-100%
- Life expectancy: At least 6 months
- 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; PT/PTT normal LDH and albumin normal
- 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; 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 in the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Physician Reliance Network, Inc.
Dallas, Texas, 75246
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
About this study
Official title: Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma
RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment.
Read the detailed description
OBJECTIVES: I. Demonstrate an objective clinical response (partial or complete) with a median duration of at least 4 months in 15% of patients with stage III or IV melanoma treated with Allovectin-7. Allovectin-7 is a direct gene transfer immunotherapeutic agent.
II. Determine the benefits, risks, and side effects of Allovectin-7 in this patient population.
PROTOCOL OUTLINE: This is a multicenter study. Patients receive an intratumoral injection of Allovectin-7 once weekly for 6 weeks. At week 9, a complete disease status assessment is performed. Patients with stable or responding disease may receive additional courses of 6 injections.
PROJECTED ACCRUAL:
A total of 70 patients will be accrued for this study.
- Conditions
- Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma
- Being tested
- allovectin-7
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2004 (estimated)
- Study startAug 1998
- Primary completionMar 2002
- Study completionMay 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jennifer Fernandez, Study chair, Vical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003646
- Sponsor's protocol ID
- CDR0000066735
- Other IDs
- VCL-1005-205
- Status last verified
- Jul 2011
- First submitted
- 1 Nov 1999
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma
- ClinicalTrials.gov ID
- NCT00003646
- Acronym / sponsor ID
- CDR0000066735
- 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 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- VicalIndustry (pharma, biotech, devices)
- Study start
- Aug 1998
- Primary completion
- Mar 2002 (actual)
- Study completion
- May 2002 (actual)
- First posted
- 3 May 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: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment.
Detailed description
OBJECTIVES: I. Demonstrate an objective clinical response (partial or complete) with a median duration of at least 4 months in 15% of patients with stage III or IV melanoma treated with Allovectin-7. Allovectin-7 is a direct gene transfer immunotherapeutic agent.
II. Determine the benefits, risks, and side effects of Allovectin-7 in this patient population.
PROTOCOL OUTLINE: This is a multicenter study. Patients receive an intratumoral injection of Allovectin-7 once weekly for 6 weeks. At week 9, a complete disease status assessment is performed. Patients with stable or responding disease may receive additional courses of 6 injections.
PROJECTED ACCRUAL:
A total of 70 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- 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 | – |
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 7 Jul 2011.
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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.
Jennifer Fernandez study chair
Vical
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing allovectin-7 in people with Stage IV Melanoma and Stage III Melanoma, run by Vical at 3 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 7 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 7 Jul 2011.