SWOG clinical trial number
S0114

An Early Phase Study of an EGFRvIII Peptide Based Vaccine in Patients With EGFRvIII Expressing Cancers

Closed
Phase
Accrual
47%
Abbreviated Title
EGFRvIII Peptide Vaccine
Activated
11/01/2002
Closed
06/01/2006
Participants
Limited: Institutions Listed on the Title Page

Research committees

Immunomolecular Therapeutics

Treatment

GM-CSF EGFRvIII Peptide Keyhole Limpet Hemocyanin

Eligibility Criteria Expand/Collapse

Paraffin block of tumor must have been submitted prior to registration as described in the protocol. Pts must have only one of the following tumors: Stage II-IV gastric cancer, Stage IIC, III, or Stage IV ovarian cancer in first complete remission, anaplastic astrocytoma, or Stage IV prostate adenocarcinoma (small cell variant is not eligible) or pts with biochemical progression after definitive therapy. Pts must be off cytotoxic chemotherapy and corticosteroids for at least 30 days prior to registration and all therapy related toxicities resolved. Zubrod PS of 0. Pts may not be simultaneously enrolled on other treatment studies. Pts must not have any contraindications to receiving GM-CSF and KLH based vaccine products. Pts must not be receiving or planning to receive any other immune modulating treatments or other tumor vaccine therapy during the planned vaccine study. Topical or inhaled steroids are acceptable. Pts must not be receiving or planning to receive chemotherapy or radiation therapy. Pts must not be pregnant or nursing. Pts of reproductive potential must have agreed to use an effective contraceptive method. Negative pregnancy test required prior to starting study as described in the protocol. No other prior malignancy is allowed except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or Stage II cancer from which the pt is in complete remission, or any other cancer from which the pt has been disease-free for 5 years. Pts must have a total WBC of greater than or equal to 3,000/ul and a Hgb greater than or equal to 10 gm/dL and a platelet count greater than or equal to 100,000/ul within 28 days prior to registration. Pts must have SGOT less than or equal to 2.5 x IULN and alkaline phosphatase less than or equal to 2.5 x IULN within 28 days prior to registration. Pts known to have autoimmune disorders or immune deficiency (including HIV and Hepatitis) are not eligible.

Other Clinical Trials

SWOG Clinical Trial Number
CTSU/A151804

ESTABLISHMENT OF A NATIONAL BIOREPOSITORY TO ADVANCE STUDIES OF IMMUNE-RELATED ADVERSE EVENTS

Research Committee(s)
Immunomolecular Therapeutics
Breast Cancer
Gastrointestinal Cancer
Genitourinary Cancer
Leukemia
Lung Cancer
Lymphoma
Melanoma
Myeloma
Early Therapeutics & Rare Cancers
Activated
06/15/2020
Open
Phase