Trial Of Cisplatin And KML-001 in Platinum Responsive Malignancies

• Status: Terminated
• Trial end date: 2015-10-27
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I Clinical Trial. Phase I studies are designed to determine the amount of investigational drugs that can be safely tolerated and to define the side effects that limit the dose. The drug administered in this study is KML-001. It is a highly soluble, orally available arsenic agent. It is currently being tested to determine its effects on telomerase activity.

In other words, the purpose of this research study is to find the highest dose of KML001, that can be given without causing severe side effects when it is combined with a standard, commercially available anti-cancer drug called cisplatin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: University of Maryland, College Park
• Treatments: Cisplatin; Sodium arsenite

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed non-small cell lung cancer or other "platinum responsive malignancies" , including but not limited to: esophageal cancer, ovarian cancer, germ cell malignancies , transitional cell cancer etc. that are not curable with chemotherapy, surgery or radiotherapy. A tissue block or fresh tissue biopsy is required. Patients with CNS (Central Nervous System) metastases which are symptomatic must have received therapy (surgery, X Ray Therapy (XRT), gamma knife) and be neurologically stable and off steroids. Patients with asymptomatic lesions without significant edema and no evidence of shift are allowed to participate without prior CNS therapy. Such patients are anticipated to receive specific CNS therapy after 2-4 courses of therapy.

• Patients may have received prior systemic chemotherapy or radiation therapy. At least 2 weeks should have elapsed since the last treatment and patients should have recovered from previous significant toxicity (i.e. to grade 1 or less). Alopecia, skin discoloration etc. are not considered significant toxicities. There is no limit on the number of prior therapies. Patients may have received prior cisplatin or other platinum regimens.

• Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.

• Patient 18 years of age or older.

• Absolute Granulocyte Count greater than or equal to 1.5 x 10^9

• Platelet count greater than or equal to 100 x 10^9

• Serum creatinine within normal limits, or an estimated or measured creatinine clearance greater than or equal to 65 ml/min.

• All patients must be informed of the investigational nature of this study and must sign and give written informed consent.

• Serum calcium, magnesium and potassium must be within normal limits.

Exclusion Criteria:

• Patients must not have serious infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment. These need not be specified in the history and physical and can be documented through signature on the eligibility checklist. Severe, active co-morbidity, defined as follows:

1. Current uncontrolled cardiac disease;

2. Corrected (Bazett) QTc interval of > .50 ms (male) or > .52 ms (female);

3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;

4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 4 weeks of registration;

5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;

6. Patients with acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition or patients known to be HIV positive.

• Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.

• Pre-existing ≥ grade 2 peripheral neuropathy.