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Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial


Phase 1
18 Years
N/A
Not Enrolling
Both
Metastatic Cancer

Thank you

Trial Information

Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial


OBJECTIVES:

- Determine the safety and toxicity of interleukin-12 gene in patients with spontaneous
skin metastases.

- Determine the antitumor immune response in patients treated with this regimen.

- Compare the toxicity of this regimen administered for 1 week vs 2 weeks in these
patients.

- Compare the local and systemic antitumor response in patients treated with this regimen
administered for 1 week vs 2 weeks.

OUTLINE: Patients are stratified according to number of tumor sites (1 vs 2 vs 3 or more).
Patients are assigned to 1 of 2 treatment arms.

- Group A: Patients receive interleukin-12 gene intratumorally over 5 minutes on days 1,
3, and 5.

- Group B: Patients receive IL-12 gene intratumorally over 5 minutes on days 1, 3, 5, 8,
10, and 12.

Patients with stable or responding disease may receive 1 subsequent course beginning on day
29.

Patients are followed at 3, 6, and 12 months.

PROJECTED ACCRUAL: A total of 12 patients (6 per treatment group) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed solid malignancy

- Surgically or medically incurable disease

- No standard chemotherapy or radiotherapy exists for this disease

- Tumor of at least 0.5 cm but no more than 2.5 cm infiltrating into or underlying the
skin

- Cutaneous metastases, subcutaneous metastases, or tumor-involved lymph nodes
that are easily palpable

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- More than 3 months

Hematopoietic:

- WBC greater than 3,000/mm^3

- Platelet count greater than 80,000/mm^3

Hepatic:

- Bilirubin less than 2.0 mg/dL

Renal:

- Creatinine less than 2.0 mg/dL

Other:

- HIV negative

- No active infections requiring antibiotic, antiviral, or antifungal treatment

- No other active malignancy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 1 month since prior immunotherapy

- No concurrent colony-stimulating factors

Chemotherapy:

- See Disease Characteristics

- At least 1 month since prior chemotherapy

Endocrine therapy:

- At least 1 month since prior steroids (other than intermittent use as an antiemetic
or topical agent)

- No concurrent steroids

Radiotherapy:

- See Disease Characteristics

- Prior radiotherapy to vaccine site allowed provided there is documentation of
progressive disease

Surgery:

- See Disease Characteristics

- No prior organ allografts

Other:

- No other concurrent antineoplastic therapy

- No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David M. Mahvi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Federal Government

Study ID:

CDR0000069115

NCT ID:

NCT00028652

Start Date:

January 2002

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • skin metastases
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792