NCT00002733

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies, including interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of biological therapies, including interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, in treating patients with metastatic cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 1996

Typical duration for phase_2

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

January 1, 1996

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2000

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

July 1, 2004

Completed
Last Updated

May 11, 2011

Status Verified

May 1, 2011

Enrollment Period

4 years

First QC Date

November 1, 1999

Last Update Submit

May 10, 2011

Conditions

Kidney CancerMelanoma (Skin)Unspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV renal cell cancerstage IV melanomaunspecified adult solid tumor, protocol specific

Interventions

aldesleukinBIOLOGICAL
recombinant interferon alfaBIOLOGICAL
therapeutic tumor infiltrating lymphocytesBIOLOGICAL
cimetidineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologic evidence of any type of cancer with metastases Melanoma or renal cell cancer preferred No active brain metastasis Tumor infiltrating lymphocytes must be available Measurable or evaluable disease preferred PATIENT CHARACTERISTICS: Age: 18 and over (under 75 preferred) Performance status: ECOG 0-3 (ECOG 0 or 1 preferred) Hematopoietic: (preferred) WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 30% (transfusion allowed) Hepatic: (preferred) Bilirubin less than 2.0 mg/dL PT/PTT normal Renal: (preferred) Creatinine less than 2.0 mg/dL Cardiovascular: (preferred) At least 6 months since prior myocardial infarction No congestive heart failure, cardiac arrhythmia, or hypertension requiring medication Pulmonary: (preferred) pO2 at least 60 mm Hg Reasonable respiratory reserve No supplemental oxygen requirement Not dyspneic at rest Other: No chronic auto-coagulation (preferred) No active infection No chronic underlying immunodeficiency disease (including HIV, hepatitis B) No known autoimmune disease Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy (7 days since stereotactic radiosurgery) Surgery: At least 4 weeks since prior surgery to control brain metastases No prior organ transplantation

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

Sponsors & Collaborators

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

Location

Related Publications (3)

  • Dillman RO, Hurwitz SR, Schiltz PM, Barth NM, Beutel LD, Nayak SK, O'Connor AA. Tumor localization by tumor infiltrating lymphocytes labeled with indium-111 in patients with metastatic renal cell carcinoma, melanoma, and colorectal cancer. Cancer Biother Radiopharm. 1997 Apr;12(2):65-71. doi: 10.1089/cbr.1997.12.65.

    PMID: 10851449BACKGROUND

  • Schiltz PM, Beutel LD, Nayak SK, Dillman RO. Characterization of tumor-infiltrating lymphocytes derived from human tumors for use as adoptive immunotherapy of cancer. J Immunother. 1997 Sep;20(5):377-86. doi: 10.1097/00002371-199709000-00007.

    PMID: 9336745BACKGROUND

  • Dillman RO, Hurwitz R, Schlitz PM, et al.: Radioimmunodetection of cancer with 111-Indium conjugated tumor infiltrating lymphocytes in patients with metastatic renal cell carcinoma. J Immunother 19(6): 457, 1996.

    BACKGROUND

MeSH Terms

Conditions

Kidney NeoplasmsMelanomaCarcinoma, Renal Cell

Interventions

aldesleukinInterferon-alphaCimetidine

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsGuanidinesAmidinesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Robert O. Dillman, MD, FACP

    Cancer Biotherapy Research Group

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 1, 2004

Study Start

January 1, 1996

Primary Completion

January 1, 2000

Study Completion

January 1, 2000

Last Updated

May 11, 2011

Record last verified: 2011-05

Locations

US(1)