NCT00004881

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2000

Longer than 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

First Submitted

Initial submission to the registry

March 7, 2000

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2000

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 25, 2004

Completed
Last Updated

June 26, 2013

Status Verified

February 1, 2001

First QC Date

March 7, 2000

Last Update Submit

June 25, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

MVA-MUC1-IL2 vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed cancer not amenable to cure by any standard modality and not suitable for accepted palliative care with chemotherapy, immunotherapy, or hormonal therapy Histologically confirmed MUC1 antigen expression No uncontrolled or symptomatic CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Hemoglobin at least 9.0 g/dL WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) Transaminase no greater than 3 times ULN (unless attributable to metastatic disease) Renal: Creatinine no greater than 2 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study HIV negative No active systemic infections No other serious concurrent systemic medical disorders that would preclude study compliance No history of, or immediate household contact with, eczema, exfoliative skin disorders, pregnant women, children under 3 years of age, or other immunocompromise offering an increased risk for disseminated vaccinia infection PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosamines and mitomycin) No concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent systemic corticosteroid therapy No concurrent hormonal therapy Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Other: No concurrent immunosuppressive drugs No other concurrent experimental protocol No other concurrent antitumor therapy

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

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Study Officials

  • Robert A. Figlin, MD, FACP

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2000

First Posted

May 25, 2004

Study Start

April 1, 2000

Study Completion

May 1, 2004

Last Updated

June 26, 2013

Record last verified: 2001-02

Locations

US(1)