Single agent intravenous (IV) mithramycin

Single agent intravenous (IV) mithramycin
Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.

Dose Level 1 - 30 mcg/kg Thoracic Malignancy

Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy

Single agent intravenous (IV) mithramycin
Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).

Dose Level -1 - 25 mcg/kg Thoracic Malignancy

Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesion, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Number of Participants With an Objective Response (Complete Response + Partial Response)

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Number of Participants With Serious and Non-Serious Adverse Events

Overall Study

Dr. David S. Schrump

Lung Cancer

Esophageal Cancer

Mesothelioma

Gastrointestinal Neoplasms

Breast Cancer

30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity

Mithramycin

National Institutes of Health Clinical Center, 9000 Rockville Pike

Mithramycin for Lung, Esophagus, and Other Chest Cancers

Phase II Evaluation of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum

David Schrump, M.D.

Principal Investigator

National Cancer Institute (NCI)

Malignant Mesothelioma

Pancreatic Cancer

Sarcoma

L-alanosine

University of Alabama at Birmingham Comprehensive Cancer Center

Arizona Cancer Center at University of Arizona Health Sciences Center

Wilshire Oncology Medical Group, Incorporated - La Verne

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

Lynn Regional Cancer Center West

University of Chicago Cancer Research Center

Midwest Cancer Research Group, Incorporated

St. Vincent's Comprehensive Cancer Center - Manhattan

Memorial Sloan-Kettering Cancer Center

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

MD Anderson Cancer Center at University of Texas

U.S. Oncology, Incorporated

Alanosine in Treating Patients With Cancer

A Phase II, Open-Label, Non-Randomized, Multicenter, Single Agent Study of Intravenous SDX-102 for the Treatment of Patients With MTAP-Deficient Cancer

Memorial Sloan Kettering Cancer Center

adenosine

sarcoma

adenosine/sarcoma

Mithramycin for Lung, Esophagus, and Other Chest Cancers

Alanosine in Treating Patients With Cancer

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