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A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma

Phase 1
18 Years
Not Enrolling
Melanoma (Skin)

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Trial Information

A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma


I. 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

II. Determine all clinical toxicities associated with this regimen in this patient

III. Determine the safety of this regimen in this patient population. IV. Assess evidence of
host antimelanoma immune reactivity following this regimen.

V. 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.

Inclusion Criteria


- 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


- 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

- 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


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Howard L. Kaufman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University


United States: Food and Drug Administration

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma



Albert Einstein Comprehensive Cancer Center Bronx, New York  10461