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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00788086 |
RATIONALE: 1-methyl-d-tryptophan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of 1-methyl-d-tryptophan in treating patients with relapsed or refractory solid tumors.
Condition | Intervention | Phase |
---|---|---|
Cancer |
Drug: 1-methyl-d-tryptophan Procedure: flow cytometry Procedure: fluorescence activated cell sorting Procedure: high performance liquid chromatography Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase I Study of 1-Methyl-D-Tryptophan (D-1MT) in Patients With Relapsed or Refractory Solid Tumors |
Estimated Enrollment: | 30 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
Blood and urine samples are collected periodically for pharmacokinetic analysis. Plasma samples are assessed for levels of D-1MT, tryptophan, and kynurenine via high performance liquid chromatography (HPLC) and for levels of regulatory CD4+, CD25+, and Foxp3 T cells via fluorescence activated cell sorting analysis. Urine samples are analyzed for clearance of D-1MT via HPLC. Tumor tissue from pre-existing samples is analyzed for indoleamine 2,3-dioxygenase (IDO) activity via IHC.
After completion of study therapy, patients are followed every 3 months for 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor malignancy
No active CNS metastases or carcinomatous meningitis
PATIENT CHARACTERISTICS:
No significant or uncontrolled cardiovascular disease, including any of the following:
No history of gastrointestinal disease causing malabsorption or obstruction, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent immunosuppressive therapy including systemic corticosteroid therapy, methotrexate, cyclosporine, tacrolimus, or sirolimus
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
Nashville, Tennessee, United States, 37064 | |
Contact: Jeffrey A. Sosman 615-936-3048 | |
Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
Nashville, Tennessee, United States, 37064 | |
Contact: Jeffrey A. Sosman 615-936-3048 | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232-6838 | |
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 |
Principal Investigator: | Jeffrey A. Sosman, MD | Vanderbilt-Ingram Cancer Center |
Responsible Party: | Vanderbilt-Ingram Cancer Center ( Jeffrey A. Sosman ) |
Study ID Numbers: | CDR0000618086, VU-VICC-PHI-0814, NLGC-NLG-2100, IRB#080257, VICTR-1855 |
Study First Received: | November 7, 2008 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00788086 |
Health Authority: | Unspecified |
adult meningioma adult teratoma benign teratoma carcinoma of the appendix chondrosarcoma chordoma clear cell sarcoma of the kidney congenital mesoblastic nephroma desmoid tumor fallopian tube cancer gastrointestinal stromal tumor hereditary neoplastic syndrome malignant conjunctival neoplasm malignant giant cell tumor of bone ovarian sarcoma |
ovarian stromal cancer ovarian teratoma peripheral nervous system neoplasm peripheral primitive neuroectodermal tumor of the kidney peritoneal cavity cancer phosphaturic mesenchymal tumor pleuropulmonary blastoma pulmonary carcinoid tumor recurrent adrenocortical carcinoma recurrent adult brain tumor recurrent adult malignant fibrous histiocytoma of bone recurrent adult primary liver cancer recurrent adult soft tissue sarcoma recurrent adult spinal cord neoplasm recurrent anal cancer |
Bone Neoplasms Histiocytoma, Benign Fibrous Malignant mesenchymal tumor Retinoblastoma Ewing's sarcoma Kaposi sarcoma Lung Neoplasms Metastatic squamous neck cancer with occult primary Oral cancer Laryngeal carcinoma Neuroepithelioma Rectal cancer Tryptophan Vaginal Neoplasms Non-small cell lung cancer |
Sarcoma, Clear Cell Breast Neoplasms Testicular Neoplasms Gall bladder cancer Carcinoma Brain Neoplasms Urethral cancer Sarcoma Uterine sarcoma Gallbladder Neoplasms Esophageal Diseases Aggressive fibromatosis Anus Neoplasms Carcinoma, Non-Small-Cell Lung Conjunctival Neoplasms |
Therapeutic Uses Psychotropic Drugs Antidepressive Agents, Second-Generation |
Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |