Cancer, Malignancy, Non Small Cell Lung Cancer, Osteosarcoma, Ovarian Cancer, Small Cell Lung Cancer, Testicular Cancer, Thymoma
Conditions
Keywords
malignancy, etoposide and carboplatin, non small cell lung cancer, small cell lung cancer, testicular cancer, thymoma, ovarian cancer, osteosarcoma
Brief summary
This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study using the 3 agents combined will begin.
Interventions
Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles
Sponsors
Alaunos Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old or greater * Malignancy scheduled to receive etoposide and carboplatin therapy * Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1 * Adequate bone marrow, liver, renal function and coagulation status * Informed consent * Agree to use birth control through 28 days of last treatment dose * Pregnancy test for women of child-bearing potential * No available standard therapy
Exclusion criteria
* Allergy to the the study treatment drugs * Unstable current medical condition * Presence or history of injury to the urinary tract * Active infection * Major surgery within 4 weeks prior to treatment * Minor surgery within 2 weeks prior to treatment * Current acute steroid therapy or taper * Currently pregnant or nursing * Substance abuse or condition that may interfere with participation * Received other investigational drugs within 30 days * Within 4 weeks of their last chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the safety profile | 21 Days | Adverse events, vital signs, physical examination, laboratory data and concomitant medications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the maximum tolerated dose | Up to 21 days | Each dose level cohort will be 3 subjects. After 3 subjects have received a regimen, there will be a minimum observation period of 1 full cycle (21 days) for each of the 3 subjects before enrollment of the group of subjects at the next dose level. |
| Assess early signs of efficacy | duration of study | To assess early signs of efficacy using this investigational combination in this patient population |
Countries
United States
Outcome results
None listed