ifosfamide and Bladder Diseases studies

Research Excerpts

Excerpt	Relevance	Reference
"Doxorubicin alone or with dacarbazine (DTIC; AD) is considered the best available therapy for metastatic adult sarcomas."	9.07	An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. ( Antman, K; Balcerzak, SP; Barlogie, B; Cooper, RM; Crowley, J; Elias, A; Natale, RB; Rivkin, SE; Trump, DL; Weiss, GR, 1993)
"Twenty-five patients with progressive or recurrent neuroblastoma were treated with single-agent ifosfamide."	9.06	Single-agent ifosfamide in patients with recurrent neuroblastoma (ENSG study 2). European Neuroblastoma Study Group. ( de Kraker, J; Hartmann, O; Ninane, J; Pritchard, J, 1987)
"We have used ifosfamide to treat patients with sarcomas in four completed single-agent protocols and one pilot study since 1985."	8.78	Single-agent ifosfamide studies in sarcomas of soft tissue and bone: the M.D. Anderson experience. ( Benjamin, RS; Legha, SS; Nicaise, C; Patel, SR, 1993)
"Doxorubicin alone or with dacarbazine (DTIC; AD) is considered the best available therapy for metastatic adult sarcomas."	5.07	An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. ( Antman, K; Balcerzak, SP; Barlogie, B; Cooper, RM; Crowley, J; Elias, A; Natale, RB; Rivkin, SE; Trump, DL; Weiss, GR, 1993)
"Twenty-five patients with progressive or recurrent neuroblastoma were treated with single-agent ifosfamide."	5.06	Single-agent ifosfamide in patients with recurrent neuroblastoma (ENSG study 2). European Neuroblastoma Study Group. ( de Kraker, J; Hartmann, O; Ninane, J; Pritchard, J, 1987)
"We have used ifosfamide to treat patients with sarcomas in four completed single-agent protocols and one pilot study since 1985."	4.78	Single-agent ifosfamide studies in sarcomas of soft tissue and bone: the M.D. Anderson experience. ( Benjamin, RS; Legha, SS; Nicaise, C; Patel, SR, 1993)
"Thirty-two patients with advanced cancer were treated in a phase I-II trial with ifosfamide plus mesnum."	1.26	Mesnum as a protector against kidney and bladder toxicity with high-dose ifosfamide treatment. ( Falkson, G; Falkson, HC; Stapelberg, R; Van Dyk, JJ, 1982)
"Mesna is a pharmacologically unremarkable, physiologically largely inert and almost totally non-toxic thio compound."	1.26	Studies on the urotoxicity of oxazaphosphorine cytostatics and its prevention--III. Profile of action of sodium 2-mercaptoethane sulfonate (mesna). ( Brock, N; Pohl, J; Scheef, W; Stekar, J, 1982)

Research

Studies (10)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Overall Survival

Timeframe	Studies, this research(%)	All Research%
pre-1990	6 (60.00)	18.7374
1990's	2 (20.00)	18.2507
2000's	1 (10.00)	29.6817
2010's	0 (0.00)	24.3611
2020's	1 (10.00)	2.80

Authors	Studies
Mills, KA	1
West, EJ	1
Grundy, L	1
McDermott, C	1
Sellers, DJ	1
Rose'Myer, RB	1
Chess-Williams, R	1
Lima, MV	1
Ferreira, FV	1
Macedo, FY	1
de Castro Brito, GA	1
Ribeiro, RA	1
Araujo, CE	1
Tessler, J	1
Falkson, G	1
Van Dyk, JJ	1
Stapelberg, R	1
Falkson, HC	1
Brock, N	2
Pohl, J	2
Stekar, J	2
Scheef, W	1
Antman, K	1
Crowley, J	1
Balcerzak, SP	1
Rivkin, SE	1
Weiss, GR	1
Elias, A	1
Natale, RB	1
Cooper, RM	1
Barlogie, B	1
Trump, DL	1
Benjamin, RS	1
Legha, SS	1
Patel, SR	1
Nicaise, C	1
Ishikawa, M	1
Takayanagi, Y	1
Sasaki, K	1
de Kraker, J	1
Pritchard, J	1
Hartmann, O	1
Ninane, J	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Determination of Tumor Response Rate by RECIST and FDG-PET Criteria to Dacarbazine in Metastatic Soft Tissue and Bone Sarcoma[NCT00802880]	Phase 2	80 participants (Actual)	Interventional	2009-03-31	Completed
Comparing the Effectiveness and Toxicity for Locally Advanced, Unresectable or Metastatic Soft-tissue Sarcoma Patients Who Had Received Total Dose of Anthracycline Antibiotics More Than 300mg/m2 With Pegylated Liposomal Doxorubicin Versus Pirarubicin Plus[NCT03342300]	Phase 2/Phase 3	0 participants (Actual)	Interventional	2017-11-06	Withdrawn (stopped due to No participants enrolled)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

(NCT00802880)
Timeframe: Until completion of follow-up or patient death (estimated to be 1 year)

Rate of Nausea/Emesis (Any Grade)

Intervention	months (Median)
Dacarbazine	8.09

Approximately 18 weeks (NCT00802880)
Timeframe: Completion of 6 cycles of treatment (18 weeks)

Rate of Neutropenia (Grade 3/4)

Intervention	percentage of participants (Number)
Dacarbazine	22.5

"Grade 3 neutropenia = absolute neutrophil count of <1000 - 500/mm^3~Grade 4 neutropenia = absolute neutrophil count of <500/mm^3" (NCT00802880)
Timeframe: Completion of 6 cycles of treatment (18 weeks)

Time to Progression (TTP)

Intervention	percentage of participants (Number)
Dacarbazine	7.5

-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00802880)
Timeframe: Until completion of follow-up (estimated to be 1 year)

Best Anatomical Tumor Response

Intervention	months (Median)
Dacarbazine	2.07

"Complete response (CR): disappearance of all target lesions, disappearance of all non-target lesions, normalization of tumor level marker~Partial response (PR): at least 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the upper limits of normal~Stable disease (SD): neither sufficient shrinkage in target lesions to qualify for PR nor sufficient increase to qualify for progressive disease taking as references the smallest sum LD since the treatment started, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits of normal~Progressive disease (PD): at least 20% increase in the sum of the LD of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions" (NCT00802880)
Timeframe: After completion of 3 cycles

Comparison of the SUV at up to 3 Tumor Sites

Intervention	participants (Number)
	Complete response	Partial response	Stable disease	Progressive disease
Dacarbazine	0	2	22	30

(NCT00802880)
Timeframe: Baseline and after every three cycles of treatment (up to 1 year)

Correlate Overall Survival With Best Anatomic Response

Correlate Overall Survival With Best Metabolic Response

Correlate the Time to Progression With Best Anatomic Response

Intervention	standard uptake value (Mean)
	Baseline	End of cycle 3	End of cycle 6	End of cycle 9	End of cycle 12
Dacarbazine	7.42	7.57	7.7	6.89	7.48

Intervention	months (Median)
	Partial response	Stable disease	Progressive disease
Dacarbazine	18.16	14.77	7.96

Intervention	months (Median)
	Partial metabolic response	Stable metabolic disease	Progressive metabolic disease
Dacarbazine	18.16	18.59	8.75

Correlate the Tumor Metabolic Response Rate With the Tumor Anatomic Response Rate

Correlate Time to Progression With Best Metabolic Response

Intervention	months (Median)
	Partial response	Stable disease	Progressive disease
Dacarbazine	NA	4.14	1.97

Intervention	participants (Number)
	PR	SD	PD	Total
Partial Metabolic Response	1	2	1	4
Progressive Metabolic Disease	1	8	24	33
Stable Metabolic Disease	0	10	2	12
Total	2	20	27	49

Overall Disease Control Rate

Overall Tumor Metabolic Response

Intervention	months (Median)
	Partial metabolic response	Stable metabolic disease	Progressive metabolic disease
Dacarbazine	3.95	5.30	2.07

Intervention	participants (Number)
	Complete response	Partial response	Stable disease	Progressive disease
Dacarbazine	0	0	5	1

"Complete metabolic response (CMR)-complete resolution of all metabolically active target and non-target lesions, and no interval development of new lesions.~Partial metabolic response (PMR)~Target lesions: 20% or greater decrease in maximum SUV from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions.~Non-target lesions: decrease in total number of non-target lesions, without complete resolution of metabolically active disease, or unequivocal decrease in degree of FDG activity within >50% of the lesions. No unequivocal new lesions.~Stable metabolic disease (SMD): does not qualify for CMR, PMR, or PMD.~Progressive metabolic disease (PMD):~Unequivocal development of one more new metabolically active lesions~Target lesion: 20% or greater increase in maximum SUV from baseline.~Non-target lesions: unequivocal increase in FDG activity" (NCT00802880)
Timeframe: After completion of 3 cycles

Article	Year
Histological changes in bladders of patients submitted to ifosfamide chemotherapy even with mesna prophylaxis. Cancer chemotherapy and pharmacology, 2007, Volume: 59, Issue:5 Topics: Adolescent; Adult; Aged; Antineoplastic Agents, Alkylating; Antineoplastic Agents, Phytogenic; Cysto	2007
Treatment of ifosfamide-induced urothelial toxicity by oral administration of sodium 2-mercaptoethane sulphonate (MESNA) to patients with inoperable lung cancer. European journal of cancer & clinical oncology, 1983, Volume: 19, Issue:2 Topics: Administration, Oral; Adult; Aged; Carcinoma, Squamous Cell; Cyclophosphamide; Drug Therapy, Combina	1983
An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 1993, Volume: 11, Issue:7 Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bone Neo	1993
An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 1993, Volume: 11, Issue:7 Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bone Neo	1993
An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 1993, Volume: 11, Issue:7 Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bone Neo	1993
An intergroup phase III randomized study of doxorubicin and dacarbazine with or without ifosfamide and mesna in advanced soft tissue and bone sarcomas. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 1993, Volume: 11, Issue:7 Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bone Neo	1993
Single-agent ifosfamide in patients with recurrent neuroblastoma (ENSG study 2). European Neuroblastoma Study Group. Pediatric hematology and oncology, 1987, Volume: 4, Issue:2 Topics: Bone Marrow Diseases; Child; Drug Evaluation; Female; Hematuria; Humans; Ifosfamide; Male; Neuroblas	1987

Article	Year
Hypersensitivity of bladder low threshold, wide dynamic range, afferent fibres following treatment with the chemotherapeutic drugs cyclophosphamide and ifosfamide. Archives of toxicology, 2020, Volume: 94, Issue:8 Topics: Animals; Antineoplastic Agents, Alkylating; Cyclophosphamide; Ifosfamide; Male; Mechanotransduction,	2020
Mesnum as a protector against kidney and bladder toxicity with high-dose ifosfamide treatment. Cancer chemotherapy and pharmacology, 1982, Volume: 9, Issue:2 Topics: Adult; Aged; Cyclophosphamide; Female; Humans; Ifosfamide; Kidney Diseases; Leukopenia; Male; Mercap	1982
Studies on the urotoxicity of oxazaphosphorine cytostatics and its prevention--III. Profile of action of sodium 2-mercaptoethane sulfonate (mesna). European journal of cancer & clinical oncology, 1982, Volume: 18, Issue:12 Topics: Animals; Cyclophosphamide; Dogs; Drug Interactions; Female; Ifosfamide; Kinetics; Lethal Dose 50; Ma	1982
Studies on the urotoxicity of oxazaphosphorine cytostatics and its prevention--I. Experimental studies on the urotoxicity of alkylating compounds. European journal of cancer, 1981, Volume: 17, Issue:6 Topics: Alkylating Agents; Animals; Cyclophosphamide; Cystitis; Dose-Response Relationship, Drug; Female; If	1981
Inhibition of ifosfamide-induced urotoxicity by disulfiram in mice. Japanese journal of pharmacology, 1989, Volume: 49, Issue:1 Topics: Administration, Oral; Animals; Disulfiram; Dose-Response Relationship, Drug; Drug Administration Sch	1989

ifosfamide and Bladder Diseases