Clinical trial · Interventional

Gene Therapy in Treating Patients With Cancer

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

NCT00004178CI-TRIAL-00004995completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cancer	Malignant Neoplasm	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
therapeutic autologous lymphocytes	Biological	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically proven CEA expressing adenocarcinoma

  * Serum CEA levels greater than 10 ng/mL
  * Failed standard therapy
* Measurable disease

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* 0-2

Life expectancy:

* Greater than 2 months

Hematopoietic:

* Not specified

Hepatic:

* No significant hepatic disease
* Bilirubin no greater than 3 mg/dL
* No active clinical disease caused by hepatitis B

Renal:

* No significant renal disease
* Creatinine no greater than 3 mg/dL

Cardiovascular:

* No significant cardiovascular disease

Pulmonary:

* No significant pulmonary disease

Other:

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No significant endocrine, rheumatologic, or allergic disease
* No active clinical disease caused by cytomegalovirus or tuberculosis
* HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 4 weeks since prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy

Surgery:

* Not specified

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Apr 1, 1998
Primary completion: Dec 1, 2000
Completion: Dec 1, 2001
First posted: Apr 19, 2004
Last update posted: Jun 10, 2011
Lead sponsor: Roger Williams Medical Center OTHER
Collaborators: Beth Israel Deaconess Medical Center
Keywords: stage III colon cancer, stage IV colon cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, recurrent non-small cell lung cancer, stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, stage III cervical cancer, recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, adenocarcinoma of the prostate, stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, adenocarcinoma of the stomach, extensive stage small cell lung cancer, recurrent small cell lung cancer, stage III vaginal cancer, stage IVA vaginal cancer, stage IVB vaginal cancer, recurrent vaginal cancer, localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent endometrial carcinoma, small intestine adenocarcinoma, unresectable gallbladder cancer, recurrent gallbladder cancer, unresectable extrahepatic bile duct cancer, recurrent extrahepatic bile duct cancer, recurrent small intestine cancer, stage III bladder cancer, recurrent bladder cancer, stage IV bladder cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer, stage IV non-small cell lung cancer, stage III salivary gland cancer, stage IV salivary gland cancer, recurrent salivary gland cancer, duct cell adenocarcinoma of the pancreas, ovarian undifferentiated adenocarcinoma, adenocarcinoma of the lung, adenocarcinoma of the esophagus, intestinal adenocarcinoma of the stomach, adenocarcinoma of the colon, diffuse adenocarcinoma of the stomach, mixed adenocarcinoma of the stomach, mucinous adenocarcinoma of the colon, signet ring adenocarcinoma of the colon, adenocarcinoma of the rectum, adenocarcinoma of the gallbladder, mucinous adenocarcinoma of the rectum, signet ring adenocarcinoma of the rectum, adenocarcinoma with squamous metaplasia of the gallbladder, adenocarcinoma of the extrahepatic bile duct, ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian clear cell cystadenocarcinoma, vaginal adenocarcinoma, vaginal clear cell adenocarcinoma, endometrial adenocarcinoma, cervical adenocarcinoma, adenocarcinoma of the bladder, salivary gland adenocarcinoma, adenocarcinoma of unknown primary, adenocarcinoma of the pancreas, stage IV pancreatic cancer

Brief summary (as posted)

Conditions (1)

Interventions (1)

Eligibility (as posted)

Publications (0)

Locations by country (1)