Granulocytic Sarcoma

Recurrent Adult Acute Myeloid Leukemia

6,8-Bis(benzylthio)octanoic Acid

Cytarabine

Hematopoietic Cell Transplantation

Mitoxantrone Hydrochloride

Comprehensive Cancer Center of Wake Forest University

CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma

An Open Label Study to Evaluate the Feasibility of CPI-613 Given With High Dose Cytarabine and Mitoxantrone in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Complete response will be compared to the observed rates in a historical cohort of subjects (CCCWFU 22111). Will use a one-sided exact test for a single proportion, a 0.05 significance level.

Will use a one-sided exact test for a single proportion, a 0.05 significance level.

The frequency of toxicities experienced by the participants will be presented by type and grade in an effort to monitor and report safety of the treatment.

Will use Kaplan-Meier estimation to analyze overall survival.

Confidence intervals will be calculated around the estimates of the response rate (CR and CRi). Assuming a response rate of 0.5, with 50 participants, 95 percent confidence intervals can be created with a 0.14 margin of error (0.36, 0.64).

Wake Forest University Health Sciences

National Cancer Institute (NCI)

Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-4 and fluorouracil IV over 46 hours on days 2-4. Courses repeat every 2 weeks for 6 months in the absence of disease progression or unacceptable toxicity.

Mucinous Adenocarcinoma of the Colon

Mucinous Adenocarcinoma of the Rectum

Recurrent Colon Cancer

Recurrent Rectal Cancer

Signet Ring Adenocarcinoma of the Colon

Signet Ring Adenocarcinoma of the Rectum

Stage IIIA Colon Cancer

Stage IIIA Rectal Cancer

Stage IIIB Colon Cancer

Stage IIIB Rectal Cancer

Stage IIIC Colon Cancer

Stage IIIC Rectal Cancer

Stage IVA Colon Cancer

Stage IVA Rectal Cancer

Stage IVB Colon Cancer

Stage IVB Rectal Cancer

6,8-bis(benzylthio)octanoic acid

fluorouracil

pharmacological study

laboratory biomarker analysis

CPI-613 and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

A Phase I Clinical Trial of Fluorouracil (5-FU) + CPI-613 Combination in Previously Treated Metastatic Colorectal Cancer Patients

Examine toxicities by assessing each toxicity by grade.

Plot a PFS curve using Kaplan-Meier methods, examine median PFS.

Assess ORR and its 95% confidence interval.

Assess DCR and its 95% confidence interval.

octanoic/sarcoma

CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma

CPI-613 and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

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