Mesothelioma Clinical Trials
Alanosine in
Treating Patients With Cancer
This study is currently
recruiting patients.
Memorial Sloan-Kettering Cancer Center
For more information:National
Cancer Institute (NCI)
RATIONALE: Drugs used in chemotherapy such as alanosine use
different ways to stop tumor cells from dividing so they stop
growing or die.
PURPOSE: Phase II trial to study the effectiveness of
alanosine in treating patients who have soft tissue sarcoma,
sarcoma of the bone, mesothelioma, non-small cell lung cancer,
or pancreatic cancer.
Condition
|
Treatment or
Intervention |
Gastrointestinal
Cancer musculoskeletal
cancer Osteosarcoma thorax and respiratory
cancer
|
Drug: alanosine
Procedure: chemotherapy
|
This is a Phase II test
- In Phase II clinical trials, the study drug or treatment
is given to a larger group of people (100-300) to see if it
is effective and to further evaluate its safety.
Study Type: Interventional Study
Design: Treatment
Official Title: Phase II Study of
Alanosine in Patients With Methylthioadenosine Phosphorylase
(MTAP)-Deficient Cancer
Further Study Details:
OBJECTIVES:
- Determine the response rates in patients with
methylthioadenosine phosphorylase (MTAP)-deficient cancer
when treated with alanosine.
- Determine the time to response and duration of response
in patients treated with this drug.
- Determine the progression-free survival of patients
treated with this drug.
- Determine the pharmacodynamic activity of this drug in
these patients, based on special imaging to measure tumor
adenosine triphosphate depletion.
- Determine the pharmacokinetic activity of this drug in
these patients.
- Determine the safety and tolerability of this drug in
these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter
study.
Patients receive alanosine IV continuously on days 1-5.
Treatment repeats every 21 days for up to 9 courses in the
absence of disease progression or unacceptable toxicity.
Patients are followed at 28 days.
PROJECTED ACCRUAL: A total of 50-145 patients (10-29 per
tumor type) will be accrued for this study.
Ages Eligible for Study: 13 Years and
above, Genders Eligible for Study: Both
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignancy of
any of the following types:
- Soft-tissue sarcoma
- High grade
- Chemotherapy naïve or progressive or metastatic after no
more than 2 prior cytotoxic treatment regimens (not
including adjuvant therapy)
- Sarcoma of the bone (including osteosarcoma* and
chondrosarcoma)
- High grade
- Progressive or recurrent after no more than 2 prior
cytotoxic treatment regimens
- No newly diagnosed or chemotherapy naïve disease NOTE:
*Prior treatment with cisplatin and doxorubicin required
- Mesothelioma
- Unresectable
- Chemotherapy naïve or progressive after no more than 1
prior cytotoxic chemotherapy regimen
- Not amenable to curative treatment with surgery
- Evidence of gross unresectability includes, but is not
limited to, direct extension into the chest wall,
mediastinal or hilar lymphadenopathy, pulmonary or cardiac
function that is inadequate to tolerate resection, and
sarcomatoid or mixed histology
- Non-small cell lung cancer
- Stage III with malignant pleural or pericardial
effusion, stage IV, or progressive after no more than 2
prior cytotoxic chemotherapy regimens
- No newly diagnosed or chemotherapy naïve disease
- Pancreatic cancer
- Stage IV adenocarcinoma after no more than 1 prior
cytotoxic treatment regimen
- No newly diagnosed or chemotherapy naïve disease
- No Ewing's sarcoma of the soft tissue or bone
- Documented absence of methylthioadenosine phosphorylase
on fixed tumor specimens
- Measurable disease
- For all tumor types, at least 1 lesion measurable by MRI
or CT scan
- Chest x-ray allowed only for clearly defined lesions
surrounded by aerated lung
- Soft tissue component of bone disease considered
measurable provided it can be measured by MRI or CT scan
- Must be outside of a previously irradiated area
- No uncontrolled CNS metastases of primary tumor under
study
- Patients with brain metastases are eligible only if the
brain metastases have been treated with prior radiotherapy
and/or surgery, are neurologically stable with no
progressing symptoms, and are off steroids and
anticonvulsants
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