Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

CDDO

Background:

* CDDO is a novel synthetic triterpenoid which is a potent multifunctional molecule. It induces apoptosis in vitro in malignant cells through both intrinsic and extrinsic pathways, and it controls cellular differentiation, apoptosis, and growth inhibition by serving as a ligand for the transcription factor peroxisome proliferator activator receptor-gamma (PPAR gamma).
* Based on in vitro activity, it holds considerable promise as a novel anti-tumor agent against a wide range of malignancies by concurrently targeting multiple pathways leading to oncogenesis.
* In vivo data demonstrates that the drug is well tolerated in dogs, and has anti-tumor effects, dependent upon dose schedule.

Objectives:

Primary:

* To determine the dose limiting toxicities, toxicity profile, and maximum tolerated dose of CDDO when administered in adult patients with solid tumors and lymphomas.
* To characterize the pharmacokinetics of CDDO.

Secondary:

* To obtain preliminary evidence of anti-tumor activity of CDDO in this population.
* To evaluate the in vivo molecular and biological effects of CDDO by assessing changes in biomarkers of apoptosis and cell cycle arrest.

Eligibility:

* Patients with advance, histological-confirmed malignancies refractory to standard therapy or for which no standard therapy exist.
* Patients should have adequate liver, renal and bone marrow function.

Study Design:

* Accordingly with the accelerated titration design 4B, dose levels will initially be increased at 100% increments, and one new patient per dose level will be treated per 4-week course.
* The accelerated phase ends when one patient experiences DLT during any course of treatment or when two different patients experience grade 2 toxicity during first course of treatment.
* When the first instance of grade 2 toxicity is observed two additional patients must have been treated at that dose, or a higher dose, (during any course) without experiencing moderate or worse toxicity, in order that the accelerated phase continue.
* When the accelerated phase ends, dose-escalation will revert to a more conservative modified Fibonacci scheme with 40% dose-step increments, with at least 3 patients treated per dose level.

CDDO to Treat Solid Tumors and Lymphomas

Phase I Study of CDDO in Solid Tumors and Lymphomas

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CDDO to Treat Solid Tumors and Lymphomas	NCT00322140	Solid Tumors Lymphoma	CDDO	18 Years -	National Institutes of Health Clinical Center (CC)
CDDO to Treat Solid Tumors and Lymphomas	NCT00322140	Solid Tumors Lymphoma	CDDO	18 Years -	National Institutes of Health Clinical Center (CC)

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