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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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.

  1. First posted6 Jun 2003 (estimated)
  2. Study startMar 2003
  3. Primary completionDec 2005
  4. Study completionDec 2009

Resources

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)
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

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.

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