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Phase I Clinical Trials of IV rhIL-12 With or Without a Test-Dose in Patients With Advanced Malignancies (rhIL-12 NSC# 672423)


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Clinical Trials of IV rhIL-12 With or Without a Test-Dose in Patients With Advanced Malignancies (rhIL-12 NSC# 672423)


OBJECTIVES:

I. Determine the toxicity profile and maximum tolerated dose (MTD) of intravenous
interleukin-12 (IL-12) administered biweekly for 6-18 weeks in the presence and absence of a
test dose in patients with metastatic or unresectable malignancies.

II. Determine the optimal timing for administration of an IL-12 test dose, based on its
impact on secondary biologic parameters in these patients.

III. Determine the antitumor effects of IL-12 administered according to this schedule, with
and without a test dose, in these patients.

IV. Determine the effect of a test dose on toxicity profile, MTD, tumor response and various
biologic phenomena in serum, and, where possible, tumor and liver in these patients.

OUTLINE: This is a 3-part dose escalation study.

In Part A, patients receive intravenous interleukin-12 (IL-12) twice a week for 6 weeks.
Courses are repeated until patients achieve a complete response or there is disease
progression. Dose escalation of IL-12 continues in cohorts of 3-6 patients until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose below that at which 2 of
6 patients experience dose limiting toxicity (DLT).

In Part B, patients receive a single test dose of IL-12 administered intravenously at a 1,
2, or 3 week interval prior to starting the multidose twice a week regimen as in Part A.
Cohorts of 4 patients will receive IL-12 at the MTD obtained in Part A.

In Part C, patients receive IL-12 at one dose level above the MTD obtained in Part A using
the optimal schedule for the test dose determined in Part B. Dose escalation continues in
cohorts of 3-6 patients until the MTD is determined. The MTD is defined as the dose below
that at which 2 of 6 patients experience DLT. Patients may continue to receive IL-12 until
they have no measurable disease or until disease progression.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed malignancy that is metastatic or unresectable and for which
standard curative or palliative measures do not exist or are no longer effective

- Advanced measurable or evaluable disease that is clearly progressive

- No brain metastases

PATIENT CHARACTERISTICS:

- Age: 18 and over

- Performance status: ECOG 0-1 Karnofsky 80-100%

- Life expectancy: At least 3 months

- WBC greater than 4,000/mm3

- Platelet count greater than 100,000/mm3

- Bilirubin less than 1.5 mg/dL

- SGOT/SGPT less than 2 times normal

- Creatinine less than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

- No congestive heart failure

- No coronary artery disease

- No serious cardiac arrhythmias

- No evidence of prior myocardial infarction on EKG

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Not HIV positive

- No seizure disorders

- No active infection that requires antibiotic therapy

- No significant medical disease other than the malignancy

PRIOR CONCURRENT THERAPY:

- No more than 2 prior biological response modifier treatment regimen

- No immunotherapy within the past 4 weeks

- No prior interleukin-12

- No more than 2 prior chemotherapy regimens

- At least 4 weeks since chemotherapy and recovered

- At least 6 weeks since nitrosoureas or mitomycin and recovered

- No concurrent chemotherapy

- At least 4 weeks since hormone therapy and recovered

- No concurrent hormone therapy

- No concurrent corticosteroids

- At least 4 weeks since radiotherapy and recovered

- No concurrent radiotherapy

- No organ allografts

- At least 2 weeks since intravenous antibiotics

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Michael B. Atkins, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000066286

NCT ID:

NCT00003330

Start Date:

July 1998

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215