Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Prostatic Neoplasms

Adenocarcinoma

Stomach Neoplasms

Breast Neoplasms

Esophageal Neoplasms

Pancreatic Neoplasms

Recurrence

Carcinoma, Ovarian Epithelial

Cholangiocarcinoma

Urinary Bladder Neoplasms

Uterine Cervical Neoplasms

Vaginal Neoplasms

Carcinoma, Renal Cell

Cystadenocarcinoma, Serous

Adenocarcinoma, Clear Cell

Adenocarcinoma of Lung

Metaplasia

Cystadenocarcinoma

Cystadenocarcinoma, Mucinous

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Esophageal Cancer

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Bile Duct Cancer

Vaginal Cancer

Renal Cell Carcinoma

Gallbladder Cancer

Adenocarcinoma of the Appendix

Lung Adenocarcinoma

Small Intestinal Adenocarcinoma

Small Intestine Cancer

All Drugs and Chemicals

Gastrointestinal Agents

Herbal and Botanical

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Pancrelipase

Pancreatin

Immunologic Factors

Cola

Escalating doses of RAV12 (weekly 0.3, 1.0, 1.5, 3.0, 4.0, 5.0, 6.0 mg/kg or 0.5 mg/kg BIW or TIW; 0.75 mg/kg BIW) for 4 weeks

monoclonal antibody RAV12

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.

OBJECTIVES:

* Determine the maximum tolerated dose of RAV12 in patients with metastatic or recurrent adenocarcinoma.
* Determine the toxicity profile of this drug in these patients.
* Determine the pharmacokinetics and immunogenicity of this drug in these patients.
* Determine, preliminarily, the antitumor activity of this drug in these patients.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive RAV12 IV over 2 hours 2-3 times per week in weeks 1-4 (course 1). Patients are evaluated for response on day 43. Patients achieving a partial or complete response may be eligible to receive additional courses of RAV12 as above. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of RAV12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Up to 15 additional patients are treated at the MTD in 1 or more patients groups (e.g., colorectal, pancreatic, gastroesophageal, and other adenocarcinoma).

After completion of study treatment, patients are followed within 4 weeks and then every 6-12 months thereafter.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma

A Phase I, Multi-Dose Study of RAV12 (ANTI-RAAG12 MAB) in Patients With Metastatic or Recurrent Adenocarcinoma

MacroGenics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma	NCT00101972	Cancer	monoclonal anti...	18 Years -	MacroGenics
RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma	NCT00101972	Cancer	monoclonal anti...	18 Years -	MacroGenics

Spots Global Cancer Trial Database for monoclonal antibody rav12