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

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vaginal Diseases

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

paclitaxel

John P. Curtin, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with advanced, refractory, or recurrent cervical or vaginal cancer.

OBJECTIVES: I. Estimate the frequency and duration of objective response, duration of progression-free interval, and survival of patients treated with paclitaxel for advanced, persistent, or recurrent clear cell adenocarcinoma of the vagina and cervix who have failed higher priority treatment protocols. II. Determine the frequency and severity of observed adverse effects on this study.

OUTLINE: Single-Agent Chemotherapy. Paclitaxel, TAX, NSC-673089.

PROJECTED ACCRUAL: 25 evaluable patients per histologic stratum will be accrued over 10-12 months for the nonsquamous cell carcinoma stratum and over 23 months for the clear cell adenocarcinoma stratum. If more than 3 patients in a given stratum respond, an additional 25 patients will be accrued to that stratum. As of 07/95, the study is open only to patients with clear cell adenocarcinoma of the vagina or cervix.

Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cervical or Vaginal Cancer

EVALUATION OF PACLITAXEL (TAXOL) IN PERSISTENT OR RECURRENT NON-SQUAMOUS CELL CARCINOMA OF THE CERVIX AND VAGINA

National Cancer Institute (NCI)

Gynecologic Oncology Group

Small Cell Lung Carcinoma

Liver Neoplasms

Adenocarcinoma, Mucinous

Small Cell Lung Cancer

Primary Liver Cancer

Hematinics

Liver Extracts

Immunoglobulins, Intravenous

therapeutic autologous lymphocytes

Richard P. Junghans, MD, PhD

RATIONALE: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill cancer cells.

PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have cancer that has not responded to previous therapy.

OBJECTIVES:

* Determine the safety and maximum tolerated dose of T cells activated in vitro and modified with chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR) in patients with CEA expressing adenocarcinoma.
* Determine the pharmacokinetics of this regimen by the persistence of modified T cells in the blood of these patients.
* Evaluate the immunogenicity of murine sequences in chimeric anti-CEA Ig TCR.
* Assess immunologic parameters which correlate with the efficacy of this regimen in these patients.
* Evaluate, in a preliminary manner, the efficacy of this regimen in patients with CEA bearing tumors.

OUTLINE: This is a dose escalation study.

Peripheral blood lymphocytes (PBL) are harvested. PBL are activated in vitro and then modified with recombinant chimeric anti-CEA immunoglobulin T cell receptors (Ig TCR). Ig TCR modified T cells are reinfused over 30-60 minutes.

The estimated maximum tolerated dose (MTD) is defined as the dose at which 2 of 6 patients experience unacceptable toxicity. If the MTD is not reached within the first cohort, a second cohort of 3 patients then receives 4 doses of modified T cells at a higher dose.

Patients are followed every 2 weeks for 2 months.

PROJECTED ACCRUAL: A total of 6-9 patients will be accrued for this study.

Gene Therapy in Treating Patients With Cancer

Phase I Study of T Cells Modified With Chimeric AntiCEA Immunoglobulin-T Cell Receptors (IgTCR) in Adenocarcinoma

Beth Israel Deaconess Medical Center

Roger Williams Medical Center

Richard Junghans

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma	NCT00101972	Cancer	monoclonal anti...	18 Years -	MacroGenics
Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cervical or Vaginal Cancer	NCT00002562	Cervical Cancer Vaginal Cancer	paclitaxel	-	National Cancer Institute (NCI)
Gene Therapy in Treating Patients With Cancer	NCT00004178	Cancer	therapeutic aut...	18 Years -	Roger Williams Medical Center
RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma	NCT00101972	Cancer	monoclonal anti...	18 Years -	MacroGenics

Spots Global Cancer Trial Database for vaginal clear cell adenocarcinoma