Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
NewLink Genetics Corporation |
---|---|
Information provided by: | NewLink Genetics Corporation |
ClinicalTrials.gov Identifier: | NCT00739609 |
This study provides an early evaluation of an entirely new class of small molecule agents directed at disruption or elimination of tumor tolerance, a phenomenon now demonstrated to be involved in the growth of many solid tumors.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Lung Cancer Melanoma Pancreatic Cancer Solid Tumors |
Drug: 1-methyl-D-tryptophan |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study of 1-methyl-D-tryptophan (D-1MT) in Patients With Relapsed or Refractory Solid Tumors |
Estimated Enrollment: | 20 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: 1-methyl-D-tryptophan
D-1MT will be administered in escalating doses. Initial dosing will be 200 mg by mouth daily with escalation planned to 2000 mg by mouth daily and potentially higher doses in subsequent cohorts if tolerated and pharmacokinetic and biologic data support further dose escalation.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Major surgery or systemic chemotherapy must have been completed at least 4 weeks prior to enrollment and residual toxicities from that therapy must be Grade 1 or lower at the time of enrollment with the exception of hemoglobin and absolute granulocyte count. Localized radiation therapy must have been completed at least 2 weeks prior to enrollment and residual toxicities must be Grade 1 or lower at the time of enrollment.
Exclusion Criteria:
United States, Tennessee | |
Vanderbilt University | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Cancer Information Program 800-811-8480 cip@vanderbilt.edu | |
Principal Investigator: Jeffrey Sosman, M.D. |
Study Chair: | Charles J. Link, M.D. | NewLink Genetics Corporation |
Responsible Party: | NewLink Genetics Corporation ( Charles J. Link, Jr., M.D. ) |
Study ID Numbers: | NLG2100 |
Study First Received: | August 20, 2008 |
Last Updated: | August 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00739609 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Pancreatic Neoplasms Psychotropic Drugs Melanoma Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Antidepressive Agents, Second-Generation Breast Diseases Antidepressive Agents Endocrine Gland Neoplasms |
Tryptophan Digestive System Neoplasms Skin Diseases Breast Neoplasms Endocrine System Diseases Neuroendocrine Tumors Neuroectodermal Tumors Digestive System Diseases Lung Diseases Gastrointestinal Neoplasms Pancreatic Diseases Nevus Endocrinopathy |
Thoracic Neoplasms Pancreatic Neoplasms Neoplasms, Nerve Tissue Psychotropic Drugs Melanoma Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Antidepressive Agents, Second-Generation Antidepressive Agents Breast Diseases Endocrine Gland Neoplasms |
Respiratory Tract Neoplasms Tryptophan Neoplasms by Histologic Type Digestive System Neoplasms Skin Diseases Breast Neoplasms Endocrine System Diseases Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Digestive System Diseases Lung Diseases Pancreatic Diseases Central Nervous System Agents |