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Adult Nasal Type Extranodal NK/T-cell LymphomaPhase 2NCT00072514

Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies

A Phase 2 study testing gemcitabine hydrochloride, carboplatin and dexamethasone in people with Adult Nasal Type Extranodal NK/T-cell Lymphoma and Anaplastic Large Cell Lymphoma, run by Fred Hutchinson Cancer Center at 1 site 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

This pilot phase II trial studies the side effects and how well giving gemcitabine hydrochloride, carboplatin, dexamethasone, and rituximab together works in treating patients with previously treated lymphoid malignancies. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
gemcitabine hydrochloride, carboplatin and dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
Aug 2003to Nov 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Patients must have relapsed or primary refractory lymphoid malignancy (including B-cell, T-cell, or Hodgkin's Disease)
  • Revised European American classification (REAL), or World Health Organization (WHO) classification of patients malignancies must be provided
  • Patients must have measurable disease defined as lesions that can be accurately measured in two dimensions by computed tomography (CT), magnetic resonance imaging (MRI), medical photograph (skin or oral lesion), plain x-ray, or other conventional technique and a greatest transverse diameter of 1 cm or greater; or palpable lesions with both diameters >= 2 cm; Note: CT scans remain the standard for evaluation of nodal disease
  • Patients must have a bone marrow aspirate and biopsy within 28 days of enrollment and no intervening anticancer therapy
  • Patients must have a CT of chest, abdomen, and pelvis within 28 days of enrollment; patients with evidence of adenopathy in the neck must have a CT of neck
  • Patients should not have evidence active central nervous system lymphoma
Show all 14Show fewer
  • Patients must have a Southwest Oncology Group (SWOG) performance status of 0, 1, or 2
  • Patients should have absolute neutrophil count (ANC) >= 1,500/uL; exception: patients with cytopenia thought to be due to disease in their bone marrow, that do not meet this criteria, may be enrolled on the protocol at the Study Chair's discretion
  • Patients should have platelets >= 100,000/uL; exception: patients with cytopenia thought to be due to disease in their bone marrow, that do not meet this criteria, may be enrolled on the protocol at the Study Chair's discretion
  • Serum bilirubin less than 2 times the upper limit of normal
  • Serum creatinine less than 1.5 times the upper limit of normal and creatinine clearance greater than 50/ mL per minute
  • Patients must have serum lactate dehydrogenase (LDH) performed within 14 days prior to treatment
  • All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
  • Must anticipate that patient will complete at least 2 cycles of chemotherapy

Who cannot join

  • Patients known to be human immunodeficiency virus (HIV) positive
  • Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
  • Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater unless approved by the Principal Investigator (PI)
  • Patients that are refractory (i.e., not responded or progressed within 6 months) to a carboplatin or cisplatin-based regimen or a gemcitabine-based regimen
  • Patients with active hepatitis B virus (HBV) infection or hepatitis
  • Patients that have other medical conditions that would contraindicate treatment with aggressive chemotherapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies

This pilot phase II trial studies the side effects and how well giving gemcitabine hydrochloride, carboplatin, dexamethasone, and rituximab together works in treating patients with previously treated lymphoid malignancies. Drugs used in chemotherapy, such as gemcitabine hydrochloride, carboplatin, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving more than one drug (combination chemotherapy) and giving monoclonal antibody therapy with chemotherapy may kill more cancer cells

Read the detailed description

OBJECTIVES:

  1. To determine the feasibility and safety of Gemcitabine/Carboplatin/Dexamethasone with or without Rituximab in previously treated lymphoid malignancies (rituximab will only be evaluated in CD20 positive malignancies).

II. To determine the efficacy of the above regimen.

III. To determine the ability to proceed to blood stem peripheral blood collection following the above regimens (the impact of above regimen on stem cell reserve).

IV. To determine remission duration.

All patients are treated with gemcitbine, carboplatin, and dexamethasone. Patients with CD20 + lymphomas also receive rituximab.

After completion of study treatment, patients are followed up at 3-4 weeks and then every 6 months for 5 years.

Medical subject headings
Lymphoma, Extranodal NK-T-Cell, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Intraocular Lymphoma, Lymphoma, B-Cell, Marginal Zone, Lymphoma, T-Cell, Peripheral, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gemcitabine hydrochlorideDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

    Given IV

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Given IV

  • dexamethasoneDrug

    Also called Aeroseb-Dex, Decaderm, Decadron, DM

    Given PO

  • rituximabBiological

    Also called IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8

    Given IV in CD20-POSITIVE LYMPHOMAS cases

Study groups in NCT00072514
Study groupRoleWhat they receive
TreatmentExperimentalPatients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.
Receives: Drug: gemcitabine hydrochloride; Drug: carboplatin; Drug: dexamethasone; Biological: rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ability to Successfully Deliver the Investigational Therapy Without Incurring the Protocol Suspension Rules

    Count of participants that received the investigational therapy without incurring the protocol suspension rules. A stopping rule for safety was employed such that the study would be suspended if sufficient evidence indicated that the true grade 4-5 non-hematologic toxicity rate exceeded 10%.

    Measured: At 3-4 weeks after completion of study treatment

Secondary outcomes (3)

  1. Overall and Complete Response Rates

    Response was assessed per standard criteria (Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria fornon-Hodgkin's lymphomas. J Clin Oncol 1999;17:1244-1253.)

    Measured: 3-4 weeks after completion of study treatment

  2. Hematologic and Non-hematologic Adverse Events.

    Count of participants with grade 3/4 hematologic and non-hematologic adverse events.

    Measured: 3-4 weeks after completion of study treatment

  3. Peripheral Blood Stem Cell Collection

    Count of patients that attempted and had successful autologous peripheral blood stem cell (PBSC) collection.

    Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2003 (estimated)
  2. Study startAug 2003
  3. Primary completionJul 2008
  4. Study completionNov 2013

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00072514
Sponsor's protocol ID
PSOC 2003
Other IDs
NCI-2011-00035
Status last verified
May 2017
First submitted
4 Nov 2003
Last updated
29 Jun 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride, carboplatin and dexamethasone in people with Adult Nasal Type Extranodal NK/T-cell Lymphoma and Anaplastic Large Cell Lymphoma, run by Fred Hutchinson Cancer Center 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?

The sponsor lists 14 inclusion and 6 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 29 Jun 2017. 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?

Yes. Results are posted in the registry (first posted 29 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Ability to Successfully Deliver the Investigational Therapy Without Incurring the Protocol Suspension Rules (time frame: At 3-4 weeks after completion of study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00072514.

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 29 Jun 2017.

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