DepoCyt for Active Lymphomatous or Leukemic Meningitis

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00523939
• Collaborator: Enzon Pharmaceuticals, Inc. (Industry)
• Enrollment: 4
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the response rate of lymphomatous meningitis or leukemic meningitis to DepoCyt. The safety of DepoCyt, the number of people who respond well to the study drug, and the response of symptoms to the study drug will also be determined.

Condition or Disease	Intervention/Treatment	Phase
Neoplastic Meningitis; Lymphoma, B Cell	Drug: cytarabine liposome injection	Phase 2

Detailed Description

DepoCyt is a sustained-release formulation of the chemotherapy drug, cytarabine (Ara-C), which is used for the treatment of patients with lymphomatous or leukemic meningitis, a complication of lymphoma/leukemia that is characterized by the spread of cancer to the central nervous system.

DepoCyt is introduced into the spinal fluid, through a needle inserted into the spinal canal or through a reservoir placed under the scalp by a neurosurgeon. DepoCyt will be given every two weeks i.e. week 1 and week 3 initially. After the second dose, a lumbar puncture will be done to check the spinal fluid for cancer cells. If there has been a good response, DepoCyt will be given every 14 days for 6 doses i.e., weeks 5, 7, 9, 11, 13, 15 and then every 28 days for six doses i.e., weeks 19, 23, 27, 31, 35, and 39. Blood tests and lumbar punctures will be done throughout the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Intrathecal Therapy With DepoCyt for Active Lymphomatous or Leukemic Meningitis
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lymphomatous Subjects with Lymphomatous Meningitis	Drug: cytarabine liposome injection; 50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses; Other Names: DepoCyt
Experimental: Leukemic Subjects with Leukemic Meningitis	Drug: cytarabine liposome injection; 50 mg intrathecal every 14 days for 8 doses, then every 28 days for six doses; Other Names: DepoCyt

Outcome Measures

Primary Outcome Measures

1. Response Rate [1 year]

   To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.

Secondary Outcome Measures

1. Time to Neurologic Progression [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Cytologically confirmed, or radiographic evidence for lymphomatous or leukemic meningitis. If the CSF cytology is negative, patients must have MRI/CT brain and clinical findings consistent with neoplastic meningitis.

• Karnofsky Performance Score of 60 or above.

• Age ≥ 18 years.

• Patients must have adequate hematologic, renal and liver function. Laboratory

• Absolute neutrophil count (ANC) ≥ 1,500/mm3 or white blood cell count > 3,000/mm3

• Platelet count ≥ 100, 000/mm3

• BUN and serum creatinine must be ≤ 1.5 times upper limit of laboratory normal

• Total and direct serum bilirubin must be ≤ 1.5 times upper limit of laboratory normal

• SGOT and SGPT ≤ 3.0 times upper limit of laboratory normal

• Alkaline phosphatase derived from liver ≤ 2.0 times upper limit of laboratory normal

• No uncontrolled infection other than human immunodeficiency virus that is being treated with anti-retroviral therapy

• Patients who have had prior CNS radiation, prior intrathecal methotrexate, and prior CNS prophylaxis with intrathecal or intravenous cytarabine or methotrexate are eligible

• Written informed consent

Exclusion Criteria:

• Experimental/Investigational chemotherapy, immunotherapy, or biologic therapy within four weeks prior to study

• Concurrent systemic chemotherapy with high dose methotrexate, high dose cytarabine, or high dose thiotepa (they cross the blood brain barrier at high levels)

• Patients receiving whole brain radiotherapy or craniospinal irradiation

• Previous (less than 2 years from diagnosis) or concurrent malignancies at other sites with the exception of fully treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin, or prostate cancer not requiring ongoing chemotherapy

• Pregnant or lactating women

• Known active meningeal infection

• Evidence of obstructive hydrocephalus requiring neurosurgical intervention

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University
• Enzon Pharmaceuticals, Inc.

Investigators

• Principal Investigator: David Rizzieri, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00523939
• Other Study ID Numbers: Pro00009742
• First Posted: Sep 3, 2007
• Last Update Posted: Jun 17, 2013
• Last Verified: Nov 1, 2012

• Keywords provided by Duke University: Lymphoma; Leukemia; Leukemic Meningitis; Lymphomatous Meningitis
• Additional relevant MeSH terms: Lymphoma; Lymphoma, B-Cell; Meningeal Carcinomatosis; Meningitis; Cytarabine

Study Results

Participant Flow

Recruitment Details	Recruitment June 2006 - September 2008. Study stopped early due to poor accrual.

Arm/Group Title	Lymphomatous	Leukemic
Arm/Group Description	Subjects with Lymphomatous Meningitis	Subjects with Leukemic Meningitis
Period Title: Overall Study
STARTED	2	2
COMPLETED	2	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lymphomatous	Leukemic	Total
Arm/Group Description	Subjects with Lymphomatous Meningitis	Subjects with Leukemic Meningitis	Total of all reporting groups
Overall Participants	2	2	4
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	2 100%	4 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	2 100%	2 100%	4 100%
Region of Enrollment (participants) [Number]
United States	2 100%	2 100%	4 100%

Outcome Measures

1. Primary Outcome

Title	Response Rate
Description	To evaluate response rate using intrathecal DepoCytTM in two cohorts of patients, one with active lymphomatous meningitis and another with active leukemic meningitis.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Primary outcome measure was not assessed due to early study termination.

Arm/Group Title	Lymphomatous	Leukemic
Arm/Group Description	Subjects with Lymphomatous Meningitis	Subjects with Leukemic Meningitis
Measure Participants	0	0

2. Secondary Outcome

Title	Time to Neurologic Progression
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lymphomatous	Leukemic
Arm/Group Description	Subjects with Lymphomatous Meningitis	Subjects with Leukemic Meningitis
Measure Participants	0	0

Adverse Events

Time Frame	9 months
Arm/Group Title	All Subjects
Arm/Group Description	Subjects with Lymphomatous or Leukemic Meningitis.
All Cause Mortality
	All Subjects
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	3/4 (75%)
General disorders
Death not associated with CTCAE term, disease progression	1/4 (25%)	1
Infections and infestations
Infection	1/4 (25%)	2
Nervous system disorders
Arachnoiditis	1/4 (25%)	1
Other (Not Including Serious) Adverse Events
	All Subjects
	Affected / at Risk (%)	# Events
Total	3/4 (75%)
Blood and lymphatic system disorders
Hemoglobin	1/4 (25%)	1
Platelets	2/4 (50%)	2
Gastrointestinal disorders
Nausea	1/4 (25%)	1
General disorders
Fatigue	1/4 (25%)	1
Pain	1/4 (25%)	3
Edema	1/4 (25%)	1
Metabolism and nutrition disorders
hypocalcemia	1/4 (25%)	1
Hyperglycemia	1/4 (25%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Slurred speech	1/4 (25%)	1
Acanthoma	1/4 (25%)	1
Nervous system disorders
Seizure	1/4 (25%)	1
Tremor	1/4 (25%)	1
Mood alteration	2/4 (50%)	2
Psychiatric disorders
Confusion	1/4 (25%)	1
Renal and urinary disorders
Urinary frequency	2/4 (50%)	2
Skin and subcutaneous tissue disorders
Rash	1/4 (25%)	1
Vascular disorders
DVT	1/4 (25%)	1

Limitations/Caveats

Adverse events for both arms, lymphomatous and leukemic, were combined due to low accrual and early study termination.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.