Melanoma (Skin)Phase 1NCT00004148
Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma
A Phase 1 study testing recombinant vaccinia-B7.1 vaccine in people with Melanoma (Skin), run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase I trial to study the effectiveness of vaccine therapy in treating patients who have unresectable metastatic melanoma. Vaccines may make the body build an immune response to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- recombinant vaccinia-B7.1 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Apr 2006
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven metastatic, unresectable melanoma Dermal, subcutaneous, or lymph node metastases
- Accessible for injection
- Lesions must measure at least 1 cm
- Patients with no prior treatment allowed
- Patients must have one of the following as proof of prior vaccinia immunization:
- Physician certification
- Recollection and appropriate vaccination scar site
- No encephalitis, untreated cerebral metastases, other structural brain lesions, or leptomeningeal disease
- No ascites or pleural effusions
- No leukemia or lymphoma
PATIENT CHARACTERISTICS:
- Age: Over 18
- Performance status: ECOG 0-1 Karnofsky 80-100%
- Life expectancy: Greater than 3 months
- WBC greater than 4,000/mm3
- Platelet count greater than 100,000/mm3
- Hemoglobin greater than 10g/dL
- Bilirubin less than 1.5 mg/dL
- Transaminases no greater than 2 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2 times ULN
- PT/PTT no greater than 2 fold elevation in patients not receiving anticoagulation medications
- No alcoholic cirrhosis
- Creatinine less than 2.0 mg/dL OR creatine clearance greater than 60 mL/min
- No congestive heart failure
- No serious cardiac arrhythmias
- No recent prior myocardial infarction
- No clinical coronary artery disease
- No chronic obstructive pulmonary disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No seizure disorders
- No underlying immunosuppressive disorder
- No autoimmune disease HIV negative
- No skin diseases
- No open wounds
- No eczema or other contraindications to vaccinia virus administration
- Patients must be able to avoid high risk individuals (e.g., immunosuppressed patients, children under 3 years, pregnant women, patients with active or a history of eczema, or patients with other skin conditions) for 7-10 days following treatment
- No significant allergy or hypersensitivity to eggs
- No active or chronic infections
- No concurrent medical illness
- No other significant medical disease which would increase risk to patient
- No other prior malignancy within the past 5 years except stage I carcinoma of the cervix or basal cell carcinoma
PRIOR CONCURRENT THERAPY:
- At least 8 weeks since prior immunotherapy and recovered
- No prior live pox virus vector
- No more than 2 prior chemotherapy regimens
- At least 4 weeks since prior chemotherapy and recovered
- At least 4 weeks since prior systemic corticosteroids
- No systemic corticosteroids for concurrent illness
- No concurrent immunosuppressive steroids
- At least 2 weeks since prior radiotherapy and recovered (no bone marrow toxicity)
- At least 6 months since prior radiotherapy for brain metastases and recovered
- At least 4 weeks since prior surgery for management of the primary or metastatic lesions and recovered with remaining measurable disease
- At least 6 months since prior surgery for brain metastases and recovered
- No concurrent immunosuppressive drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
About this study
Official title: A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma
Phase I trial to study the effectiveness of vaccine therapy in treating patients who have unresectable metastatic melanoma. Vaccines may make the body build an immune response to kill tumor cells.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of the rV-B7.1 vaccine that elicits a host immune response and is associated with acceptable toxicity in patients with malignant metastatic melanoma.
II. Determine all clinical toxicities associated with this regimen in this patient population.
III. Determine the safety of this regimen in this patient population. IV. Assess evidence of host antimelanoma immune reactivity following this regimen.
- Determine the effect of this regimen on T-cell immunity. VI. Assess the clinical response in this patient population receiving this regimen.
VII. Evaluate quality of life of these patients during this regimen.
OUTLINE: This is a dose escalation study.
Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities.
Quality of life is assessed before treatment, every 4 weeks, and at end of treatment. Patients are followed every 3 months.
- Conditions
- Melanoma (Skin)
- Being tested
- recombinant vaccinia-B7.1 vaccine
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant vaccinia-B7.1 vaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities. Receives: Biological: recombinant vaccinia-B7.1 vaccine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2004 (estimated)
- Study startOct 1999
- Primary completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Howard L. Kaufman, MD, Study chair, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004148
- Sponsor's protocol ID
- CDR0000067380
- Other IDs
- AECM-99-101, NCI-T99-0006
- Status last verified
- Jun 2006
- First submitted
- 10 Dec 1999
- Last updated
- 11 Feb 2013
- Results posted
- No
Publications
Kaufman HL, Deraffele G, Mitcham J, Moroziewicz D, Cohen SM, Hurst-Wicker KS, Cheung K, Lee DS, Divito J, Voulo M, Donovan J, Dolan K, Manson K, Panicali D, Wang E, Horig H, Marincola FM. Targeting the local tumor microenvironment with vaccinia virus expressing B7.1 for the treatment of melanoma. J Clin Invest. 2005 Jul;115(7):1903-12. doi: 10.1172/JCI24624. Epub 2005 Jun 2.
PubMed 15937544Kaufman HL, Conkright W, Divito J Jr, Horig H, Kaleya R, Lee D, Mani S, Panicali D, Rajdev L, Ravikumar TS, Wise-Campbell S, Surhland MJ. A phase I trial of intra lesional RV-B7.1 vaccine in the treatment of malignant melanoma. Hum Gene Ther. 2000 May 1;11(7):1065-82. doi: 10.1089/10430340050015374. No abstract available.
PubMed 10811235
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00004148
- Acronym / sponsor ID
- CDR0000067380
- Conditions
- Melanoma (Skin)
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Oct 1999
- Primary completion
- Apr 2006 (actual)
- First posted
- 20 Feb 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.
Phase I trial to study the effectiveness of vaccine therapy in treating patients who have unresectable metastatic melanoma. Vaccines may make the body build an immune response to kill tumor cells.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of the rV-B7.1 vaccine that elicits a host immune response and is associated with acceptable toxicity in patients with malignant metastatic melanoma.
II. Determine all clinical toxicities associated with this regimen in this patient population.
III. Determine the safety of this regimen in this patient population. IV. Assess evidence of host antimelanoma immune reactivity following this regimen.
- Determine the effect of this regimen on T-cell immunity. VI. Assess the clinical response in this patient population receiving this regimen.
VII. Evaluate quality of life of these patients during this regimen.
OUTLINE: This is a dose escalation study.
Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities.
Quality of life is assessed before treatment, every 4 weeks, and at end of treatment. Patients are followed every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: recombinant vaccinia-B7.1 vaccinePatients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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 |
|---|---|---|
| recombinant vaccinia-B7.1 vaccine | Biological | Arm I |
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 11 Feb 2013.
- Results publication: PubMed 15937544Kaufman HL, Deraffele G, Mitcham J, Moroziewicz D, Cohen SM, Hurst-Wicker KS, Cheung K, Lee DS, Divito J, Voulo M, Donovan J, Dolan K, Manson K, Panicali D, Wang E, Horig H, Marincola FM. Targeting the local tumor microenvironment with vaccinia virus expressing B7.1 for the treatment of melanoma. J Clin Invest. 2005 Jul;115(7):1903-12. doi: 10.1172/JCI24624. Epub 2005 Jun 2.
- Results publication: PubMed 10811235Kaufman HL, Conkright W, Divito J Jr, Horig H, Kaleya R, Lee D, Mani S, Panicali D, Rajdev L, Ravikumar TS, Wise-Campbell S, Surhland MJ. A phase I trial of intra lesional RV-B7.1 vaccine in the treatment of malignant melanoma. Hum Gene Ther. 2000 May 1;11(7):1065-82. doi: 10.1089/10430340050015374. No abstract available.
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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.
Howard L. Kaufman, MD study chair
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing recombinant vaccinia-B7.1 vaccine in people with Melanoma (Skin), run by National Cancer Institute (NCI) at 1 site 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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
On the ClinicalTrials.gov record for NCT00004148, which also lists 2 linked publications.
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 11 Feb 2013.