NCT00003330

Brief Summary

Phase I trial to study the effectiveness of interleukin-12 in treating patients who have advanced cancer. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

May 20, 2004

Completed
Last Updated

February 11, 2013

Status Verified

May 1, 2001

Enrollment Period

3.8 years

First QC Date

November 1, 1999

Last Update Submit

February 8, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Arms (1)

Arm I

EXPERIMENTAL

See detailed description.

Biological: recombinant interleukin-12

Interventions

recombinant interleukin-12BIOLOGICAL
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • Gollob JA, Mier JW, Veenstra K, McDermott DF, Clancy D, Clancy M, Atkins MB. Phase I trial of twice-weekly intravenous interleukin 12 in patients with metastatic renal cell cancer or malignant melanoma: ability to maintain IFN-gamma induction is associated with clinical response. Clin Cancer Res. 2000 May;6(5):1678-92.

    PMID: 10815886RESULT

  • Gollob JA, Veenstra KG, Mier JW, Atkins MB. Agranulocytosis and hemolytic anemia in patients with renal cell cancer treated with interleukin-12. J Immunother. 2001 Jan-Feb;24(1):91-8. doi: 10.1097/00002371-200101000-00011.

    PMID: 11211153RESULT

MeSH Terms

Interventions

Interleukin-12 Subunit p35

Intervention Hierarchy (Ancestors)

Interleukin-12InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Michael B. Atkins, MD

    Beth Israel Deaconess Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 20, 2004

Study Start

July 1, 1998

Primary Completion

April 1, 2002

Last Updated

February 11, 2013

Record last verified: 2001-05

Locations

US(1)