RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma (NCT00101972) | Clinical Trial Compass
CompletedPhase 1
RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma
United States53 participantsStarted 2004-12
Plain-language summary
RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase I trial is studying the side effects and best dose of RAV12 in treating patients with metastatic or recurrent adenocarcinoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma
* Metastatic or recurrent disease
* Not curable by standard therapies
* Must have failed at least 1, but no more than 3, prior therapies for metastatic or recurrent disease
* Patients with colorectal or breast adenocarcinoma must have failed at least 2 prior therapies
* Must have had at least stable disease for 3 months while on last treatment prior to most recent disease progression
* Meets 1 of the following criteria:
* At least 1 measurable site of disease ≥ 2 cm by radiography
* Evaluable disease that could be reliably and consistently followed, as deemed by the principal investigator
* RAAG12 expression confirmed\* by immunohistochemistry NOTE: \*Not required for patients with colon, pancreatic, or gastric adenocarcinoma
* No evidence of residual or recurrent CNS metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Not specified
Menopausal status
* Not specified
Performance status
* ECOG 0-1
Life expectancy
* More than 3 months
Hematopoietic
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
* Absolute neutrophil count ≥ 1,500/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* γ-glutamyl transferase ≤ 2.5 times ULN
* Adequate hepatic function sufficient to undergo study therapy
Renal
* Creatinine \< 1.5 mg/d…