Lung CancerPhase 2NCT00062283
Alanosine in Treating Patients With Cancer
A Phase 2 study testing L-alanosine in people with Lung Cancer and Malignant Mesothelioma, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy such as alanosine use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well alanosine works in treating patients with soft tissue sarcoma, sarcoma of the bone, mesothelioma, non-small cell lung cancer, or… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Lung Cancer, Malignant Mesothelioma, Pancreatic Cancer
- What is being tested?
- L-alanosine
- How many people
- Not given
- Where
- 12 sitesUnited States
- Study dates
- Mar 2003to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
PATIENT CHARACTERISTICS:
Age
- 18 and over (13 and over for osteosarcoma only)
Performance status
- WHO 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
- AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are present)
Renal
- Creatinine no greater than 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 4 weeks after study treatment
- No premalignant bony lesions (e.g., Paget's disease)
- No other concurrent active malignancy except completely excised nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder
- No serious infection
- No medical or psychiatric condition that would preclude the achievement of the study objectives
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- More than 42 days since prior nitrosoureas or mitomycin
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- See Disease Characteristics
- At least 28 days since prior brain radiotherapy
- More than 28 days since prior radiotherapy to more than 50% of the bone marrow
Surgery
- See Disease Characteristics
- At least 28 days since prior thoracic or other major surgery
Other
- Recovered from prior therapy
- More than 28 days since prior cytotoxic agents
- More than 28 days since prior anticancer investigational agents
- No other concurrent anti-tumor treatment
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
Lynn Regional Cancer Center West
Boca Raton, Florida, 33428
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
MD Anderson Cancer Center at University of Texas
Houston, Texas, 77030
U.S. Oncology, Incorporated
Houston, Texas, 77060
Wilshire Oncology Medical Group, Incorporated - La Verne
La Verne, California, 91750
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, 90048
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232-6838
St. Vincent's Comprehensive Cancer Center - Manhattan
New York, New York, 10011
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Midwest Cancer Research Group, Incorporated
Skokie, Illinois, 60077
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724
About this study
Official title: A Phase II, Open-Label, Non-Randomized, Multicenter, Single Agent Study of Intravenous SDX-102 for the Treatment of Patients With MTAP-Deficient Cancer
RATIONALE: Drugs used in chemotherapy such as alanosine use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well alanosine works in treating patients with soft tissue sarcoma, sarcoma of the bone, mesothelioma, non-small cell lung cancer, or pancreatic cancer.
Read the detailed description
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.
- Conditions
- Lung Cancer, Malignant Mesothelioma, Pancreatic Cancer, Sarcoma
- Being tested
- L-alanosine
- Keywords
- advanced malignant mesothelioma, recurrent malignant mesothelioma, metastatic osteosarcoma, recurrent osteosarcoma, recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, chondrosarcoma, recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage III adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage IV pancreatic cancer
- Medical subject headings
- Lung Neoplasms, Mesothelioma, Malignant, Pancreatic Neoplasms, Sarcoma, Osteosarcoma, Chondrosarcoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-alanosineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2003 (estimated)
- Study startMar 2003
- Primary completionDec 2005
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Paul A. Meyers, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062283
- Sponsor's protocol ID
- SALMEDIX-SDX-102-01
- Other IDs
- MSKCC-03029, CDR0000304677
- Status last verified
- Dec 2009
- First submitted
- 5 Jun 2003
- Last updated
- 26 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Non-Randomized, Multicenter, Single Agent Study of Intravenous SDX-102 for the Treatment of Patients With MTAP-Deficient Cancer
- ClinicalTrials.gov ID
- NCT00062283
- Acronym / sponsor ID
- SALMEDIX-SDX-102-01
- Conditions
- Lung Cancer, Malignant Mesothelioma, Pancreatic Cancer, Sarcoma
- Keywords
- advanced malignant mesothelioma, recurrent malignant mesothelioma, metastatic osteosarcoma, recurrent osteosarcoma, recurrent adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, chondrosarcoma, recurrent non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Jun 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy such as alanosine use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well alanosine works in treating patients with soft tissue sarcoma, sarcoma of the bone, mesothelioma, non-small cell lung cancer, or pancreatic cancer.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-alanosine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A. Meyers, MD study chair
Memorial Sloan Kettering Cancer Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-alanosine in people with Lung Cancer and Malignant Mesothelioma, run by Memorial Sloan Kettering Cancer Center at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.