Lymphoma, Non-HodgkinPhase 2NCT00000801
Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
A Phase 2 study testing Filgrastim, Vincristine sulfate and Doxorubicin hydrochloride in people with Lymphoma, Non-Hodgkin and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in United States.
Trial summary
To estimate the response rate, overall and disease-free survival, toxicities, factors associated with outcome, and effect on quality of life in patients with AIDS-related primary CNS lymphoma treated with CHOD (cyclophosphamide, doxorubicin, vincristine, and dexamethasone) plus filgrastim (granulocyte-colony… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, HIV Infections
- What is being tested?
- Filgrastim, Vincristine sulfate and Doxorubicin hydrochloride
- How many people
- 33 participants
- Where
- 7 sitesUnited States
- Study dates
- Start not givento Apr 1998
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication: Required:
- PCP prophylaxis with Bactrim, dapsone, or aerosolized pentamidine.
- Oral candidiasis prophylaxis with fluconazole, ketoconazole, or clotrimazole oral troches.
- Antiretroviral agent available by therapy IND.
- MAI prophylaxis with rifabutin (in patients with CD4 counts < 100 cells/mm3).
- Patients must have:
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- HIV infection.
- Primary CNS lymphoma with NO systemic involvement.
- Prior Medication:
- Allowed:
- Prior corticosteroids.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Concomitant malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin.
- Active uncontrolled infection.
- Renal failure, active nonmalignant duodenal ulcer, uncontrolled diabetes mellitus, or other serious medical conditions that would preclude aggressive cytotoxic chemotherapy administration.
- Active heart disease (congestive heart failure or heart block greater than first degree on EKG).
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- Concurrent Medication:
- Excluded:
- Any investigational agent other than antiretroviral agents available by therapy IND.
- Patients with the following prior conditions are excluded:
- No prior malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous cell or basal cell carcinoma of the skin.
- No new infectious complications within the past 2 weeks that require a change in antibiotics.
- History of myocardial infarction within the past 3 months.
- Prior Medication:
- Excluded:
- Prior chemotherapy other than for Kaposi's sarcoma.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
ECOG Data Management Office
Brookline, Massachusetts, 02146
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Mount Sinai Med Ctr
New York, New York, 10029
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
San Francisco Gen Hosp
San Francisco, California, 941102859
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
To estimate the response rate, overall and disease-free survival, toxicities, factors associated with outcome, and effect on quality of life in patients with AIDS-related primary CNS lymphoma treated with CHOD (cyclophosphamide, doxorubicin, vincristine, and dexamethasone) plus filgrastim (granulocyte-colony stimulating factor; G-CSF) and external beam irradiation. To determine other clinical markers present in this patient population.
Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma.
Read the detailed description
Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma.
Patients who upon staging workup are found to be without systemic involvement undergo one cycle of chemotherapy with cyclophosphamide, doxorubicin, vincristine, dexamethasone, and G-CSF. Cyclophosphamide, doxorubicin, and vincristine are administered intravenously on day 1. Dexamethasone is administered intravenously on day 1 and then orally thereafter with gradual discontinuation. G-CSF is administered subcutaneously daily beginning on day 2 and continuing for a total of 10 days or until blood counts have recovered to an acceptable level. Patients with evidence of cancer cells in their cerebrospinal fluid (CSF) will receive chemotherapy with intrathecal cytarabine twice weekly until no further evidence of cancer cells is found in the CSF, then once weekly for 6 weeks, and then monthly for 10 months. Seven to ten days following completion of one cycle of chemotherapy, patients undergo radiotherapy to the brain at a dose of 2.5 Gy daily for 5 days per week for approximately 4 weeks. Total dose to the whole brain and meninges is 30.0 Gy in 12 fractions, and total dose to the primary boost volume is 10.0 Gy in 4 fractions. During therapy, blood is drawn weekly and brain scans are performed every 3-12 weeks. An initial CSF sample will be obtained by lumbar puncture.
- Conditions
- Lymphoma, Non-Hodgkin, HIV Infections
- Being tested
- Filgrastim, Vincristine sulfate, Doxorubicin hydrochloride, Cyclophosphamide, Cytarabine
- Keywords
- Vincristine, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin, Granulocyte Colony-Stimulating Factor, Combined Modality Therapy, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, Combined, Brain Neoplasms, Lymphoma, High-Grade, Lymphoma, Intermediate-Grade
- Medical subject headings
- Lymphoma, Non-Hodgkin, HIV Infections, Acquired Immunodeficiency Syndrome, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgrastimDrug
CyclophosphamideDrug
CytarabineDrug
DexamethasoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionApr 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Enrolment
- 33 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Krigel RL, Study chairVon Roenn J, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000801
- Sponsor's protocol ID
- ACTG 252
- Other IDs
- ECOG E 1493
- Status last verified
- Oct 2012
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2012
- Results posted
- No
Publications
Schultz C, Scott C, Sherman W, Donahue B, Fields J, Murray K, Fisher B, Abrams R, Meis-Kindblom J. Preirradiation chemotherapy with cyclophosphamide, doxorubicin, vincristine, and dexamethasone for primary CNS lymphomas: initial report of radiation therapy oncology group protocol 88-06. J Clin Oncol. 1996 Feb;14(2):556-64. doi: 10.1200/JCO.1996.14.2.556.
PubMed 8636771
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT00000801
- Acronym / sponsor ID
- ACTG 252
- Conditions
- Lymphoma, Non-Hodgkin, HIV Infections
- Keywords
- Vincristine, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin, Granulocyte Colony-Stimulating Factor, Combined Modality Therapy, Acquired Immunodeficiency Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Apr 1998 (actual)
- First posted
- 31 Aug 2001 (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.
To estimate the response rate, overall and disease-free survival, toxicities, factors associated with outcome, and effect on quality of life in patients with AIDS-related primary CNS lymphoma treated with CHOD (cyclophosphamide, doxorubicin, vincristine, and dexamethasone) plus filgrastim (granulocyte-colony stimulating factor; G-CSF) and external beam irradiation. To determine other clinical markers present in this patient population.
Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma.
Detailed description
Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma.
Patients who upon staging workup are found to be without systemic involvement undergo one cycle of chemotherapy with cyclophosphamide, doxorubicin, vincristine, dexamethasone, and G-CSF. Cyclophosphamide, doxorubicin, and vincristine are administered intravenously on day 1. Dexamethasone is administered intravenously on day 1 and then orally thereafter with gradual discontinuation. G-CSF is administered subcutaneously daily beginning on day 2 and continuing for a total of 10 days or until blood counts have recovered to an acceptable level. Patients with evidence of cancer cells in their cerebrospinal fluid (CSF) will receive chemotherapy with intrathecal cytarabine twice weekly until no further evidence of cancer cells is found in the CSF, then once weekly for 6 weeks, and then monthly for 10 months. Seven to ten days following completion of one cycle of chemotherapy, patients undergo radiotherapy to the brain at a dose of 2.5 Gy daily for 5 days per week for approximately 4 weeks. Total dose to the whole brain and meninges is 30.0 Gy in 12 fractions, and total dose to the primary boost volume is 10.0 Gy in 4 fractions. During therapy, blood is drawn weekly and brain scans are performed every 3-12 weeks. An initial CSF sample will be obtained by lumbar puncture.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- PCP prophylaxis with Bactrim, dapsone, or aerosolized pentamidine.
- Oral candidiasis prophylaxis with fluconazole, ketoconazole, or clotrimazole oral troches.
- Antiretroviral agent available by therapy IND.
- MAI prophylaxis with rifabutin (in patients with CD4 counts < 100 cells/mm3).
- HIV infection.
Key exclusion criteria (16 listed)
- Concomitant malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin.
- Active uncontrolled infection.
- Renal failure, active nonmalignant duodenal ulcer, uncontrolled diabetes mellitus, or other serious medical conditions that would preclude aggressive cytotoxic chemotherapy administration.
- Active heart disease (congestive heart failure or heart block greater than first degree on EKG).
- Any investigational agent other than antiretroviral agents available by therapy IND.
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 |
|---|---|---|
| Filgrastim | Drug | – |
| Vincristine sulfate | Drug | – |
| Doxorubicin hydrochloride | Drug | – |
| Cyclophosphamide | Drug | – |
| Cytarabine | Drug | – |
| Dexamethasone | 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 1 Nov 2012.
- Background: PubMed 8636771Schultz C, Scott C, Sherman W, Donahue B, Fields J, Murray K, Fisher B, Abrams R, Meis-Kindblom J. Preirradiation chemotherapy with cyclophosphamide, doxorubicin, vincristine, and dexamethasone for primary CNS lymphomas: initial report of radiation therapy oncology group protocol 88-06. J Clin Oncol. 1996 Feb;14(2):556-64. doi: 10.1200/JCO.1996.14.2.556.
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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.
Krigel RL study chair
Von Roenn J study chair
7 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 Filgrastim, Vincristine sulfate and Doxorubicin hydrochloride in people with Lymphoma, Non-Hodgkin and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 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?
The sponsor lists 11 inclusion and 16 exclusion criteria. 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 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
On the ClinicalTrials.gov record for NCT00000801, which also lists 1 linked publication.
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 1 Nov 2012.