LeukemiaPhase 2NCT00003340
Cyclophosphamide Plus Topotecan in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
A Phase 2 study testing cyclophosphamide and topotecan hydrochloride in people with Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide plus topotecan in treating patients who have refractory or relapsed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- cyclophosphamide and topotecan hydrochloride
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 1997to Feb 2000
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven acute myelogenous leukemia by bone marrow aspirate or biopsy Clear evidence of relapse or residual disease with greater than 5% blasts on bone marrow examination or greater than 30% peripheral blasts No active CNS leukemia Not eligible for potentially curative allogeneic or autologous bone marrow transplantation without further surgery Must have failed to achieve a complete remission with conventional chemotherapy (cytarabine based) or have relapsed within 12 months after initial remission
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.6 mg/dL (unless due to disease) Renal: Creatinine less than 1.6 mg/dL (unless due to disease) No prior hemorrhagic cystitis Other: Not pregnant Fertile patients must use effective contraception No active uncontrolled infection
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Must have recovered from prior radiotherapy Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Oncology Center
Baltimore, Maryland, 21287
About this study
Official title: A Phase II Study of Cyclophosphamide Followed by Topotecan in Patients With Refractory or Relapsed Acute Myelogenous Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide plus topotecan in treating patients who have refractory or relapsed acute myelogenous leukemia.
Read the detailed description
OBJECTIVES: I. Evaluate the efficacy of cyclophosphamide followed by topotecan in patients with relapsed or refractory acute myelogenous leukemia. II. Confirm safety and tolerability of this combination on this schedule in these patients.
OUTLINE: Patients receive cyclophosphamide intravenously over 1 hour on day 1 followed by topotecan as a continuous 120 hour infusion starting 12 hours after completion of cyclophosphamide. Treatment may be repeated every 3-6 weeks for at least 2 courses.
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
- Conditions
- Leukemia
- Being tested
- cyclophosphamide, topotecan hydrochloride
- Keywords
- recurrent adult acute myeloid leukemia
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
topotecan hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2004 (estimated)
- Study startNov 1997
- Primary completionFeb 2000
- Study completionFeb 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Carole Miller, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003340
- Sponsor's protocol ID
- J9736 CDR0000066314
- Other IDs
- JHOC-97100102, J-9736, NCI-G98-1435
- Status last verified
- May 2014
- First submitted
- 1 Nov 1999
- Last updated
- 2 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Cyclophosphamide Followed by Topotecan in Patients With Refractory or Relapsed Acute Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT00003340
- Acronym / sponsor ID
- J9736 CDR0000066314
- Conditions
- Leukemia
- Keywords
- recurrent adult acute myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 1997
- Primary completion
- Feb 2000 (actual)
- Study completion
- Feb 2000 (actual)
- First posted
- 16 Aug 2004 (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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide plus topotecan in treating patients who have refractory or relapsed acute myelogenous leukemia.
Detailed description
OBJECTIVES: I. Evaluate the efficacy of cyclophosphamide followed by topotecan in patients with relapsed or refractory acute myelogenous leukemia. II. Confirm safety and tolerability of this combination on this schedule in these patients.
OUTLINE: Patients receive cyclophosphamide intravenously over 1 hour on day 1 followed by topotecan as a continuous 120 hour infusion starting 12 hours after completion of cyclophosphamide. Treatment may be repeated every 3-6 weeks for at least 2 courses.
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| cyclophosphamide | Drug | – |
| topotecan hydrochloride | 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 2 May 2014.
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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.
Carole Miller, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cyclophosphamide and topotecan hydrochloride in people with Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site 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 2 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 May 2014.